Fidelity Of Intervention Implementation Research Articles

Amplitude training in occupational therapy for the treatment of Parkinson's disease: a feasibility study

Background/Aims Parkinson Wellness Recovery Moves is a functional, large-amplitude exercise programme aimed at reducing the symptoms of Parkinson's disease. To date, evidence supports the use of amplitude training to reduce the symptoms of Parkinson's disease; however, evidence is lacking in the feasibility of using Parkinson Wellness Recovery Moves as an adjunct to occupational therapy within inpatient rehabilitation. The aim of this study was to evaluate the feasibility of implementing the Parkinson Wellness Recovery Moves intervention into the treatment of patients with Parkinson's disease, within an inpatient rehabilitation hospital. Methods A total of five adults with Parkinson's disease participated in this 11-week quasi-experimental feasibility trial. The use of Parkinson Wellness Recovery Moves was standardised, requiring each participant to engage in at least two occupational therapy sessions that included Parkinson Wellness Recovery Moves. Outcomes collected included fidelity of intervention implementation, and participant-centred outcomes of quality of life satisfaction and function via the Parkinson's Disease Questionnaire-39 and Section GG respectively. Results Each participant had a positive change in Section GG scores and completed between eight and 13 occupational therapy sessions that included Parkinson Wellness Recovery Moves. Four out of five participants reported higher quality of life at the time of discharge. Conclusions The use of Parkinson Wellness Recovery Moves was found to be feasible to implement within an inpatient rehabilitation hospital, with increased functional performance and improved quality of life.

Abbreviating the Early Start Denver Model for community-based family-centered care.

Parent-mediated approaches for young children with or with a higher likelihood of autism have gained traction, with mounting evidence of efficacy, but a research-to-gap practice exists, and community effectiveness remains to be firmly established. Using a community-participatory framework, a total of 10 parent-child dyads received a five-day workshop and six follow-up sessions of ESDM parent coaching. Intervention was implemented across two phases with in-person and telehealth delivery. From pre to post intervention across both phases, parents improved in their fidelity of intervention implementation and children maid gains on proximal measures of social communication. Community delivery of an evidence-based parent-mediated interventions for toddlers on the autism spectrum is feasible and promising. Giving resource efficiencies associated with parent-mediated approaches, particularly when delivered through government-funded programs, findings bolster current efforts to promote earlier and more widespread community access to necessary interventions. Facilitators and barriers to supporting parent learning and behavior change via interactive strategies are discussed.

Examining fidelity reporting within studies of foundational reading interventions for elementary students with or at risk for dyslexia.

Early access to evidence-based reading intervention improves outcomes for students with or at risk for reading difficulties. Additionally, teacher implementation of reading interventions plays a key role in the efficacy of reading interventions. Previous research suggests the influence of intervention implementation fidelity on student language and literacy outcomes is more significant for lower-performing students and students with disabilities, such as dyslexia. However, recent syntheses have suggested that less than half of reading intervention studies report treatment fidelity data. This meta-analysis examined fidelity reporting within reading intervention studies for students with or at risk for dyslexia in Grades K-5. We aimed to record the frequency and extent of fidelity reporting, explore associations between study or intervention features and fidelity reporting, and compare mean intervention effect sizes for studies reporting fidelity and those that did not. A total of 51 studies were included. Results indicated that 75% of studies reported fidelity data. Studies reporting fidelity primarily focused on adherence and dosage data with little to no information reported for other dimensions of fidelity (i.e., quality, responsiveness, differentiation). Suggestions for improving reporting of treatment fidelity data are discussed.

Instructional coaching actions that predict teacher classroom practices and student achievement

Although there is emerging evidence supporting the efficacy of instructional coaching models used to support teachers in schools, additional research is necessary to investigate the individual contributions of coaching actions for specific approaches. This study investigated the extent to which three coaching actions—modeling, practice, and feedback—provided during data-driven coaching predicted (a) teachers' intervention implementation fidelity, (b) teachers' use of evidence-based classroom strategies, and (c) class-wide student achievement. In addition, the study explored the potential mediating influence of teachers' intervention implementation fidelity on the relationship between coaching actions and teachers' use of evidence-based strategies. Participants included 16 instructional coaches, one from each of 16 high-poverty charter schools, and 133 coached K–12 classroom teachers assigned to 3649 students. Results from multiple regression analyses indicated that the provision of practice opportunities during coaching was a statistically significant predictor, with greater practice opportunities associated with greater teacher intervention implementation fidelity and greater class-wide student English Language Arts (ELA) and math achievement. Feedback during coaching predicted student ELA but not math achievement. Both practice and feedback opportunities predicted better teacher use of evidence-based classroom strategies. In addition, teachers' intervention implementation fidelity mediated the relationship between teacher practice opportunities and teachers' use of evidence-based classroom strategies. Modeling was not found to be a statistically significant predictor. Study limitations and implications for practice and future research are described.

Implementing Remote Developmental Research: A Case Study of a Randomized Controlled Trial Language Intervention During COVID-19.

Intervention studies with developmental samples are difficult to implement, in particular when targeting demographically diverse communities. Online studies have the potential to examine the efficacy of highly scalable interventions aimed at enhancing development, and to address some of the barriers faced by underrepresented communities for participating in developmental research. During the COVID-19 pandemic, we executed a fully remote randomized controlled trial (RCT) language intervention with third and fourth grade students (N = 255; age range 8.19–10.72 years, mean = 9.41, SD = 0.52) from diverse backgrounds across the United States. Using this as a case study, we discuss both challenges and solutions to conducting an intensive online intervention through the various phases of the study, including recruitment, data collection, and fidelity of intervention implementation. We provide comprehensive suggestions and takeaways, and conclude by summarizing some important tradeoffs for researchers interested in carrying out such studies.

Effects of Teachers as Coaches for Paraprofessionals Implementing Functional Communication Training

Young children with intensive behavioral needs are often served by paraprofessionals, who are typically among the least trained and least supported staff in the school. While professional development opportunities to address challenging behavior are generally limited for special education teachers, such professional growth opportunities are often completely unavailable for paraprofessionals. The purpose of this study was to evaluate a program in which teachers served as coaches for paraprofessionals. Using a multiple-baseline design across paraprofessional-and-child dyads, we evaluated the effects of the teachers-as-coaches program on paraprofessional implementation fidelity and child engagement in challenging behavior and appropriate communication. The results showed that with teacher coaching, paraprofessionals increased their behavior intervention implementation fidelity to 100%. During the maintenance probes, two of the paraprofessionals implemented the intervention with 100% fidelity, and the third paraprofessional implemented the intervention with higher fidelity than baseline. Results also showed corresponding decreases in child challenging behavior and increases in appropriate communication. Implications for research and practice in supporting paraprofessionals are discussed.

Designing Interventions for Implementation in Schools: A Multimethod Investigation of Fidelity of a Self-Monitoring Intervention

Interventions for youth are often studied in school settings, yet there are barriers that hinder schools from actively participating in the research studies. To ensure interventions are studied in the context they are intended for, adopted in a timely manner, and regularly used in practice as designed, researchers can conduct studies in a manner that reflects the dynamic needs of schools. Participatory action research, which engages participants in the research process, and coproduction of interventions, which involves end users in the development of interventions, are complementary frameworks that may increase the utility and flexibility of school-based interventions while also improving engagement and fidelity of intervention implementation. This study explored the implementation of a self-monitoring intervention, Self-Management And Regulation Training Strategy (SMARTS), developed using these approaches. Using multiple methods, findings indicate that school counselors (i.e., natural treatment agents) valued helping in the development of SMARTS and were able to implement it in school settings with fidelity. In fact, the quality with which they implemented components of the intervention was significantly related to students’ engagement in intervention procedures. Implications and limitations are discussed.

A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer

BackgroundFear of cancer recurrence (FCR) is common in people affected by breast cancer. FCR is associated with increased health service and medication use, anxiety, depression and reduced quality of life. Existing interventions for FCR are time and resource intensive, making implementation in a National Health Service (NHS) setting challenging. To effectively manage FCR in current clinical practice, less intensive FCR interventions are required. Mini-AFTERc is a structured 30-min counselling intervention delivered over the telephone and is designed to normalise moderate FCR levels by targeting unhelpful behaviours and misconceptions about cancer recurrence.This multi-centre non-randomised controlled pilot trial will investigate the feasibility of delivering the Mini-AFTERc intervention, its acceptability and usefulness, in relation to specialist breast cancer nurses (SBCNs) and patients. This protocol describes the rationale, methods and analysis plan for this pilot trial of the Mini-AFTERc intervention in everyday practice.MethodsThis study will run in four breast cancer centres in NHS Scotland, two intervention and two control centres. SBCNs at intervention centres will be trained to deliver the Mini-AFTERc intervention. Female patients who have completed primary breast cancer treatment in the previous 6 months will be screened for moderate FCR (FCR4 score: 10‑14). Participants at intervention centres will receive the Mini-AFTERc intervention within 2 weeks of recruitment. SBCNs will audio record the intervention telephone discussions with participants. Fidelity of intervention implementation will be assessed from audio recordings. All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months. Normalisation process theory (NPT) will form the framework for semi-structured interviews with 20% of patients and all SBCNs. Interviews will explore participants’ experience of the study, acceptability and usefulness of the intervention and factors influencing implementation within clinical practice. The ADePT process will be adopted to systematically problem solve and refine the trial design.DiscussionFindings will provide evidence for the potential effectiveness, fidelity, acceptability and practicality of the Mini-AFTERc intervention, and will inform the design and development of a large randomised controlled trial (RCT).Trial registrationClinicalTrials.gov: NCT0376382. Registered 4th December 2018, https://clinicaltrials.gov/ct2/show/NCT03763825

Play to Teach: Coaching Paraeducators to Facilitate Communication in the Preschool Classroom.

Paraeducators are ideal candidates for delivering communication interventions to children with developmental disabilities and delays (DD) because they spend a significant amount of time with these children. However, professional development is often inadequate and limited research supports best practices. Additionally, paraeducators work with multiple children with varying skill levels. Little research has been conducted on the use of existing strategies with multiple children. This single-case study examines the effect of a training package on paraeducators' fidelity of intervention implementation with a child dyad and subsequent child outcomes. Results suggest that formal coaching contributed to improved fidelity of intervention implementation. Furthermore, paraeducators were able to use intervention strategies with children with varying communication skills and goals. Variable increases in child communication were also detected.

Pivotal response treatment: A study into the relationship between therapist characteristics and fidelity of implementation.

In this study, we investigated the relationship between fidelity of pivotal response treatment implementation and therapist characteristics, such as therapist personality, therapist–child relationship, therapist attitude toward evidence-based practices, and therapist experience. We also explored whether child age and autism symptom severity were related to pivotal response treatment fidelity. Participants were 41 level III certified pivotal response treatment therapists who recorded three 10-min pivotal response treatment sessions and completed four questionnaires to measure therapist characteristics. Results indicated that therapists’ attitude toward evidence-based practices, specifically openness to innovation, and therapists’ experience with pivotal response treatment significantly predicted fidelity of pivotal response treatment implementation. Cross-validation methods largely confirmed these findings. Therapist personality, therapist–child relationship, and child characteristics were not significantly related to pivotal response treatment fidelity. Implications for clinical practice and directions for future research are discussed.Lay abstractPivotal response treatment is a naturalistic behavioral intervention that teaches pivotal skills to children with autism spectrum disorder to produce widespread gains in other skills. Although most children with autism spectrum disorder benefit from pivotal response treatment, intervention outcomes vary considerably among children. Fidelity of intervention implementation (i.e. the extent to which an intervention is implemented as intended) may affect intervention outcomes. In this study, we studied the relationship between fidelity of pivotal response treatment implementation and therapist characteristics, such as therapist personality, therapist–child relationship, therapist attitude toward evidence-based practices, and therapist experience. We also explored whether a child’s age and autism symptom severity were related to pivotal response treatment fidelity. Participants were 41 pivotal response treatment therapists who videotaped three pivotal response treatment sessions and completed four questionnaires to measure therapist characteristics. This study found that therapists’ openness to innovation and their experience with pivotal response treatment predicted fidelity of implementation. Therapist personality, therapist–child relationship, and child characteristics were not related to pivotal response treatment fidelity. The results of this study emphasize that it is important (1) to target therapists’ attitudes toward innovation prior to or during training in pivotal response treatment and (2) to provide therapists with ongoing supervision and feedback after training to increase fidelity of implementation and thus to improve intervention outcomes for children with autism spectrum disorder.

Role of Organizational Support on Implementation of an Environmental Change Intervention to Improve Child Fruit and Vegetable Intake: a Randomized Cross-Over Design.

Little is known about the role of organizational or administrative support in implementation of health promotion interventions, particularly outside of school settings. The purpose was to determine the change in fruit and vegetable (FV) intake among children living in residential children's homes (RCHs) and assess the relationships among change in organizational support, intervention implementation, and child nutrition outcomes. Data were collected from 29 RCHs and 614 children living in RCHs, as part of a group randomized design with delayed intervention, at three cross-sectional waves: 2004, 2006, and 2008. RCH staff made environmental changes to increase intake of FV. Implementation and organizational support data were collected from staff at the RCHs. Child FV intake were measured via 24-h dietary recalls. A two-way (condition by time) repeated measures ANOVA was conducted to test whether FV intake increased in response to the intervention. A two-level path analysis with a robust maximum likelihood estimator was used to explore the relationships among organizational support, intervention implementation fidelity, and child FV intake. There was a significant increase in FV intake within all RCHs from 2004 to 2006 (P = 0.022 for the intervention group, P = 0.015 for the control group). This increase was maintained in both groups from 2006 to 2008 (post-intervention mean servings: intervention = 3.2 vs control = 3.4). Increases in organizational support resulted in greater overall implementation fidelity. When RCH staff, supervisors, and the RCH CEO were perceived to be supportive of the intervention, more environmental changes were made to encourage eating FV. Fostering organizational support may improve implementation of interventions.

Promoting high-leverage writing instruction through an early childhood classroom daily routine (WPI): A professional development model of early writing skills

This study presents an initial investigation of a professional development intervention model for promoting preschool teachers’ high-leverage writing instruction through a modification of the “Morning Meeting Time” (MMT) classroom routine. Using a quasi-experimental design, 14 teachers and 112 children were assigned to intervention and comparison conditions. Intervention group teachers received a four-hour workshop and one in-classroom coaching session focused on modifying existing MMT routine activities to implement interactive writing instruction. Results indicate that intervention group teachers achieved high intervention implementation fidelity and significantly improved the quality of their writing instruction (Cohen’s d ranges from 1.22 to 2.36). Further, despite a relatively brief intervention phrase (three months), intervention group children showed greater gains in name writing, letter writing, and letter naming skills than comparison group children (Cohen’s d ranges from 1.28 to 1.59). Findings provide initial evidence for the merit of utilizing typically occurring classroom routines, such as Morning Meeting, for embedding explicit teaching and writing opportunities for young children.

Effects of coaching on the fidelity of parent implementation of reciprocal imitation training.

Imitation is an important early social communicative skill that is often impaired in young children with autism. Reciprocal imitation training is an easy-to-implement intervention that targets social imitation and can be taught to parents or other caregivers to implement at home and in the community. In this study, parents of children with autism were taught to implement reciprocal imitation training. The quality of parent fidelity of intervention implementation and rates of child spontaneous imitation were examined in three phases: baseline, post-didactic training, and after the introduction of 1:1 coaching. The results suggest that coaching improved parent fidelity with all parent participants, and this correlated to an increase in spontaneous imitation with some of the child participants.

A Cluster Randomized Controlled Trial of a Total Worker Health® Intervention on Commercial Construction Sites.

This study evaluated the efficacy of an integrated Total Worker Health® program, “All the Right Moves”, designed to target the conditions of work and workers’ health behaviors through an ergonomics program combined with a worksite-based health promotion Health Week intervention. A matched-pair cluster randomized controlled trial was conducted on ten worksites (five intervention (n = 324); five control sites (n = 283)). Worker surveys were collected at all sites pre- and post- exposure at one- and six-months. Linear and logistic regression models evaluated the effect of the intervention on pain and injury, dietary and physical activity behaviors, smoking, ergonomic practices, and work limitations. Worker focus groups and manager interviews supplemented the evaluation. After controlling for matched intervention and control pairs as well as covariates, at one-month following the ergonomics program we observed a significant improvement in ergonomic practices (B = 0.20, p = 0.002), and a reduction in incidences of pain and injury (OR = 0.58, p = 0.012) in the intervention group. At six months, we observed differences in favor of the intervention group for a reduction in physically demanding work (B = −0.25, p = 0.008), increased recreational physical activity (B = 35.2, p = 0.026) and higher consumption of fruits and vegetables (B = 0.87, p = 0.008). Process evaluation revealed barriers to intervention implementation fidelity and uptake, including a fissured multiemployer worksite, the itinerant nature of workers, competing production pressures, management support, and inclement weather. The All the Right Moves program had a positive impact at the individual level on the worksites with the program. For the longer term, the multi-organizational structure in the construction work environment needs to be considered to facilitate more upstream, long-term changes.

Classroom Management That Works: A Replication Trial of the CW-FIT Program

The present study examined the effects of the Class-Wide Function-Related Intervention Team (CW-FIT) program, a group contingency intervention addressing the on-task and disruptive behavior of students with or at risk for emotional behavior disorders (EBD). Twenty-one elementary schools, 155 general education teachers, and 324 students participated in the multisite efficacy trial of CW-FIT over 6 months. Procedures included teaching attending skills, setting goals and awarding points for appropriate behavior, and differential reinforcement and rewards. Students not responding to the primary-level intervention received self-management or help cards as Tier 2 supports. Fidelity of intervention implementation was high across 4 years, with fidelity checks across groups and during baseline conditions. The primary outcome variables of engagement, disruptive behavior, and teacher praise and reprimands were assessed with repeated direct observation. Results confirmed that CW-FIT can be used to increase on-task behavior and reduce disruptive behavior of students with or at risk for EBD.

Expressive writing intervention promotes resilience among juvenile justice-involved youth

Youth involved in child welfare and juvenile justice systems suffer from alarmingly high rates of mental health challenges. In particular, exposure to trauma (e.g., maltreatment) is one critical experience that amplifies their risk for delinquency and recidivism. Despite a profound need to address these youth's mental health needs, there is a paucity of trauma-informed and youth-centered treatments that are clinically feasible in under-resourced residential settings (e.g., juvenile detention facilities). In response to this gap, our research team collaborated with the juvenile justice subsection of a large American city's child welfare system with the goal of creating an intervention tailored to the needs of underserved system-involved youth. The resultant program, WRITE ON (Writing and Reflecting on Identity To Empower Ourselves as Narrators), leverages research on the therapeutic benefits of expressive writing to implement a brief, cost-effective intervention in youth residential settings. This paper describes intervention development and presents findings from the pilot study, which comprised a multisite experimental evaluation of youth (N=53) residing in short-term detention facilities. This pilot study aimed to: 1) assess intervention implementation fidelity, including participant satisfaction, and 2) evaluate the mental health outcomes of youth receiving WRITE ON as compared to those in a comparison support group (CSG). Results indicated that the intervention was delivered with good fidelity, participants reported high levels of satisfaction, and WRITE ON participants exhibited significant (p<0.01) gains in resilience compared to their counterparts in the CSG. Collectively, results suggest that a larger clinical trial investigating the effectiveness of WRITE ON with system-involved youth is warranted.

Assessing the feasibility of evaluating and delivering a physical activity intervention for pre-school children: a pilot randomised controlled trial.

BackgroundFew evidence-based physical activity interventions for pre-school children are available. This two-armed pilot cluster randomised controlled trial aimed to evaluate the feasibility of conducting a full-scale trial and of delivering an outdoor physical activity intervention for pre-school children.MethodsSchool was the unit of randomisation, and follow-up occurred at 10 and 52 weeks. Trial feasibility was assessed by recruitment, retention and completion rates of primary (daily moderate-to-vigorous physical activity (MVPA)) and secondary (anthropometric, quality of life, self-efficacy) outcomes. Potential effectiveness was assessed for the primary outcome using a linear regression model comparing MVPA between trial arms adjusting for clustering by school. Feasibility of delivering the intervention was assessed by intervention fidelity and attendance. Semi-structured interviews with parents, intervention facilitators, and head teachers explored acceptability and capability to deliver the intervention as well as acceptability of the study design.ResultsRecruitment rates were 37 % of schools (n = 10 schools) and 48 % of pre-school children (n = 164 children). Retention of children to the trial at 52 weeks was 83.5 %. Thirty-nine percent of children had valid primary outcome accelerometer data at baseline and 52 weeks. Response rates for secondary outcome measures ranged from 52 to 88 % at 10 weeks and 59 to 80 % at 52 weeks. The mean difference in daily MVPA between trial arms at 52 weeks was 0.4, 95 % CI 16.3 to 17.0; p = 0.96. Fidelity of intervention implementation was 81 %. Intervention attendance was higher (82 %) during the summer initiation phase compared to autumn/spring initiation (50 %). Parents, facilitators and head teachers found the intervention acceptable and beneficial.ConclusionsRecruitment and retention rates suggest a trial in this outdoor setting with this population was feasible but is weather sensitive. However, strategies to increase accelerometer wear-time would need to be implemented for reliable primary outcome data to be obtained. There was high implementation fidelity by facilitators, and the intervention was seen as acceptable and deliverable. However, attendance was low and preliminary data showed no evidence of intervention effectiveness. A revised intervention, building on the successful elements of this pilot alongside adapting implementation strategies to improve attendance, should therefore be considered.Trial registrationTrial registry name and number: Current Controlled Trials, ISRCTN54165860. Date of registration: 4 September 2012.

The Effect of a Meditative Movement Intervention on Quality of Sleep in the Elderly: A Systematic Review and Meta-Analysis.

Sleep disorders are one of the most common difficulties facing older people. Meditative movement interventions (MMIs), a new category of exercise integrating physical activity and meditation (e.g., t'ai chi, yoga, and qigong), may benefit older people with sleep problems. This systematic review synthesized the evidence on the effect of MMIs on older people's quality of sleep. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, the Cochrane Library, the China Science and Technology Journal Database (CSTJ) and the China National Knowledge Infrastructure (CNKI) were searched-from 1950 to March 2014-for randomized controlled trials. Articles were screened and selected by two researchers. Data were extracted from the included studies using specified forms. The same researchers independently evaluated the quality of each article. A meta-analysis was conducted to examine the pooled effect of MMI on sleep quality compared with the control groups. Fourteen of 1049 studies were included, involving 1225 participants. Interventions included t'ai chi, yoga, qigong, and multicomponent MMI and lasted 12-24 weeks. Ten studies had a low risk of bias. The interventions resulted in significantly better sleep quality scores than either active therapy or usual care/wait-list controls (standardized mean difference, -0.70;95% confidence interval, -0.96 to -0.43). Subgroup analyses revealed that the effect of MMI on sleep quality was not influenced by the type or duration of the intervention. However, pooled results of studies with intervention frequency of fewer than 3 times per week did not show a positive effect on sleep quality. Lower-quality studies had larger effect sizes than high-quality studies. No adverse events were reported. The current review demonstrated that MMI had a moderate effect on improving the quality of sleep for older people with sleep complaints. However, the evidence is inconclusive because of the varying study quality and MMI modalities. This study highlights the need for higher-quality randomized, controlled trials and more sufficient fidelity of intervention implementation to confirm the results. It also highlights the need for comparing the effectiveness of MMI on different subgroups of the elderly population.

Preschoolers in the Playground: a pilot cluster randomised controlled trial of a physical activity intervention for children aged 18 months to 4 years

BackgroundThe preschool years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood and establishing habitual physical activity early in life is therefore vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school-aged children. There are few preschool, playground-based interventions and these have given inconclusive results. A report published by the UK’s Chief Medical Officer (CMO) highlighted the need for new interventions to promote movement in the early years (0–5 years).ObjectivesThis study aimed to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged from 18 months to 4 years (Preschoolers in the Playground or PiP) and to assess the feasibility of conducting a full-scale cluster RCT.DesignThe study was a two-armed pilot cluster RCT with economic and qualitative evaluations. Participants were randomised on a 1 : 1 basis to the PiP intervention (n = 83) or usual practice (control;n = 81).SettingBradford, West Yorkshire, UK.ParticipantsChildren aged from 18 months to 4 years.InterventionThe PiP intervention is grounded in behavioural theory (social cognitive theory) and is in accordance with CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. The intervention was delivered in primary school playgrounds. Six 30-minute PiP sessions per week were available for 30 weeks; families were encouraged to come to three a week. The 10-week initiation phase was facilitated by a member of school staff and the maintenance phase was unsupervised.Main outcome measuresRecruitment and retention of schools and families to the trial were the main outcome measures. The acceptability of trial procedures and the intervention, the feasibility of collecting health outcome data and the fidelity of the implementation of the intervention were also evaluated. A preliminary assessment of cost-effectiveness and a sample size calculation for a full trial were conducted.ResultsIn total, 37% of schools and 48% of parents approached agreed to take part. Levels of retention were good at 10 and 52 weeks’ follow-up (82.3% and 83.5% respectively). Both the trial procedures and the intervention were acceptable. However, attendance was low during the autumn and winter/spring initiation phases but somewhat better in the summer initiation phase. Attendance was poor throughout all maintenance phases. The accelerometry protocol for measuring physical activity requires modification. The fidelity of intervention implementation was good (81% adherence). The intervention was borderline cost-effective. A sample size of 600 children from 38 schools is required for a full trial.ConclusionA full RCT of the PiP intervention is feasible. The PiP intervention requires some modification, for example running the intervention during the summer term only, but was found to be acceptable to schools and families.Trial registrationCurrent Controlled Trials ISRCTN54165860.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 5. See the NIHR Journals Library website for further project information.

Fidelity of Intervention Implementation: A Review of Instruments

Background: Interventions, whether simple or complex, are increasing in health care in response to the growing complexity and acuity of patient’s conditions. Monitoring the fidelity of implementing interventions is challenging. A common method to assess and monitor fidelity of intervention implementation is through a structured, reliable and valid instrument. Purpose: The purpose of this paper is to examine existing instruments measuring fidelity of intervention implementation in order to determine aspects of fidelity that have been assessed and reported on the reliability and validity of these instruments. Design: A descriptive review was conducted. Studies were included if they described and reported on the fidelity of intervention implementation instruments, their psychometric properties were published between 1980 and 2015. Methods: Data were extracted on the study characteristics, levels and aspects of fidelity and the psychometric properties, specifically the reliability and validity of the fidelity of intervention implementation instruments. Results: In total, 21 studies were included in the review. Overall results showed that some aspects and levels of fidelity of intervention implementation are included in the instruments. At the theoretical level, fidelity of intervention implementation is not accounted for majority of the studies and few explicitly reports on the use of instruments to evaluate intervention differentiation. At the operational level, interventionists’ adherence and competence are included in the instruments; however, participants’ engagement, exposure and enactment are not. The instruments demonstrate acceptable level of validity and reliability. Conclusion: Sustained focus on developing psychometrically sound instruments that account for all levels (i.e. theoretical and operational) and aspects of fidelity of intervention implementation is imperative to strengthen the methodological literature for interventions research; and for researchers to correctly interpret research findings and to arrive at valid conclusions on the effectiveness of interventions, whether simple or complex.