Delayed Intervention Condition Research Articles

A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol

BackgroundYoung sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group.MethodsThis study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13–18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up.DiscussionBehavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group.Trial registrationClinicalTrials.gov number, NCT03167606, registered May 30, 2017.

A Pilot Intervention Trial to Promote Sexual Health and Stress Management Among HIV-Infected Men Who Have Sex with Men.

Men who have sex with men (MSM) experience HIV disparities. This study pilot-tested a two session, group-delivered intervention to promote sexual health and stress management skills for HIV-infected MSM. Participants (N = 80) were randomized to an immediate or delayed intervention condition. Analyses of covariance examined intervention efficacy. Compared to the delayed condition, intervention condition participants reported: greater HIV transmission knowledge (p < .001), higher HIV disclosure self-efficacy (p = .004), stronger intentions to refuse unprotected sex (p = .05), decreased frequency of unprotected anal or oral sex (p = .03), decreased perceived stress levels (p = .03), and higher coping self-efficacy (p = .003). Differences in the number of unprotected anal sex episodes, condom attitudes, and level of social support did not differ between conditions. Findings provide evidence of intervention acceptability and suggest the brief intervention may enhance stress management skills and modify sexual risk behavior antecedents for HIV-infected MSM.

Increasing Social Support for Breakfast: Project BreakFAST.

The intervention included school policy changes in 16 schools randomized to intervention and delayed-intervention conditions, in order to allow quick and easy access to breakfast as well as to allow breakfast consumption in classrooms and hallways; a School Breakfast Program marketing campaign to address normative and attitudinal beliefs; and increasing social support and role modeling to encourage breakfast eating. The participants in the study completed an online survey at baseline and again postintervention. The final analysis included only students who completed the relevant survey (n = 904) items on both the baseline and follow-up surveys. The students in the intervention group showed a higher level of social support post intervention than the control group with a significant adjusted p of .02. Most of the overall social support change was explained by a change in the "other kids at my school" and "other school staff" categories. The BreakFAST study shows the benefits of school staff and kids other than friends supporting a behavior change to include breakfast consumption in adolescents.

Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial

BackgroundDepression has become one of the leading contributors to the global disease burden. Evidence-based treatments for depression are available, but access to them is still limited in some instances. As technology has become more integrated into mental health care, computerized cognitive behavioral therapy (CBT) protocols have become available and have been recently transposed to mobile environments (e.g., smartphones) in the form of “apps.” Preliminary research on some depression apps has shown promising results in reducing subthreshold or mild to moderate depressive symptoms. However, this small number of studies reports a low statistical power and they have not yet been replicated. Moreover, none of them included an active placebo comparison group. This is problematic, as a “digital placebo effect” may explain some of the positive effects documented until now. The aim of this study is to test a newly developed mobile app firmly grounded in the CBT theory of depression to determine whether this app is clinically useful in decreasing moderate depressive symptoms when compared with an active placebo. Additionally, we are interested in the app’s effect on emotional wellbeing and depressogenic cognitions.Methods/designRomanian-speaking adults (18 years and older) with access to a computer and the Internet and owning a smartphone are included in the study. A randomized, three-arm clinical trial is being conducted (i.e., active intervention, placebo intervention and delayed intervention). Two hundred and twenty participants with moderate depressive symptoms (i.e., obtaining scores >9 and ≤16 on the Patient Health Questionnaire, PHQ-9) will be randomized to the three conditions. Participants undergoing therapy, presenting serious mental health problems, or legal or health issues that would prevent them from using the app, as well as participants reporting suicidal ideation are excluded. Participants randomized to the active and placebo interventions will use the smartphone app for 6 weeks. A short therapist check-in via phone will take place every week. Participants in the delayed-intervention condition will be given access to the app after 6 weeks from randomization. The primary outcome is the level of depressive symptomatology. The intervention delivered through the app to the active condition includes psychoeducational materials and exercises based on CBT for depression, while the placebo intervention uses a sham version of the app (i.e., similar structure of courses and exercises).DiscussionTo our knowledge, this study protocol is the first to test the efficacy of a smartphone app for depressive symptomatology in the form of a randomized controlled trial (RCT) that includes an active placebo condition. As such, this can substantially add to the body of evidence supporting the use of apps designed to decrease depression.Trial registrationClinicalTrials.gov, identifier: NCT03060200. Registered on 1 February 2017. The first participant was enrolled on 17 February 2017.

Strategic Persuasive Writing Instruction for Students with Emotional and Behavioral Disabilities

Expressive writing is important for school and life success, but remains challenging for many students with emotional and behavioral disabilities. Emerging evidence reveals promise for teaching students with learning and behavioral issues to improve written expression with self-regulated strategy development instruction. In that research, students are taught to criterion performance (e.g., demonstrating mastery performance for each lesson) for instructional periods sometimes as long as 50 days (see Mastropieri et al., 2009). What is unknown, however, is given the more limited time constraints within a school setting, whether students with emotional disabilities, many with comorbidity, can successfully improve within a school's allocated time for teaching persuasive essays. The current study used a waitlist comparison condition and randomly assigned 32 eighth graders to either an immediate intervention or a waitlist delayed intervention condition during which an organizational and planning strategy for writing persuasive essays was taught. Findings revealed students were able to successfully learn and apply the strategy within a reduced time period as evidenced by statistically significant higher quality essays that contained more essay elements, words, sentences, and transition words. Student interviews revealed positive attitudes toward instruction and strategy use. Two months following posttesting, surprise maintenance measures were administered that yielded equivocal results suggesting periodic review sessions may be appropriate. Implications for the classroom practice are discussed.

A cluster randomized trial of an organizational process improvement intervention for improving the assessment and case planning of offenders: a Study Protocol.

BackgroundThe Organizational Process Improvement Intervention (OPII), conducted by the NIDA-funded Criminal Justice Drug Abuse Treatment Studies consortium of nine research centers, examined an organizational intervention to improve the processes used in correctional settings to assess substance abusing offenders, develop case plans, transfer this information to community-based treatment agencies, and monitor the services provided by these community based treatment agencies.Methods/DesignA multi-site cluster randomized design was used to evaluate an inter-agency organizational process improvement intervention among dyads of correctional agencies and community based treatment agencies. Linked correctional and community based agencies were clustered among nine (9) research centers and randomly assigned to an early or delayed intervention condition. Participants included administrators, managers, and line staff from the participating agencies; some participants served on interagency change teams while other participants performed agency tasks related to offender services. A manualized organizational intervention that includes the use of external organizational coaches was applied to create and support interagency change teams that proceeded through a four-step process over a planned intervention period of 12 months. The primary outcome of the process improvement intervention was to improve processes associated with the assessment, case planning, service referral and service provision processes within the linked organizations.DiscussionProviding substance abuse offenders with coordinated treatment and access to community-based services is critical to reducing offender recidivism. Results from this study protocol will provide new and critical information on strategies and processes that improve the assessment and case planning for such offenders as they transition between correctional and community based systems and settings. Further, this study extends current knowledge of and methods for, the study of evidence-based practice adoption and implementation.Electronic supplementary materialThe online version of this article (doi:10.1186/2194-7899-2-1) contains supplementary material, which is available to authorized users.

Computerized stress management training for HIV+ women: a pilot intervention study

HIV+women have unique psychosocial stressors, but few interventions have been designed for this population. To address this gap in the literature, we developed a brief, theory-guided, computer-administered, stress management intervention for HIV+ women. To obtain initial evidence of the intervention's efficacy, we recruited 60 HIV+ female participants (70% African American) and randomized them to an immediate or delayed intervention condition. Psychological functioning, perceived stress, coping self-efficacy, and stress management knowledge were assessed at baseline and at a one month follow-up. Compared with the delayed treatment control group, women who received the intervention demonstrated improved stress management knowledge at the follow-up (p<0.01). However, depressive symptoms, psychological distress, perceived stress, and coping self-efficacy did not differ between the immediate and delayed intervention groups (ps>0.05). Computerized psychosocial interventions require continued refinement to meet the needs of HIV+ women.

Reductions in Drug Use Among Young People Living with HIV

ZIP models were used to detect reductions in drug abuse among young people living with HIV (YPLH) over 15 months when most young people abstain from use. YPLH (n = 171) aged 16 to 29 years were randomly assigned to an 18 session intervention or a delayed-intervention condition. The ZIP models showed significant reductions in abuse of multiple substances over time in the non-delayed intervention. Previous analyses did not find significant reductions. Intervention efficacy often cannot be detected if there are highly skewed distributions of outcomes, such as drug abuse. ZIP modeling offers an opportunity to more reliably detect behavioral changes.

Coaching Process Outcomes of a Family Visit Nutrition and Physical Activity Intervention

The purpose of this article is to report the process outcomes of a coaching methodology used in a study designed to increase fruit and vegetable consumption and physical activity in families. Eighty-eight families with second graders were recruited from a rural, biethnic community in Colorado and randomized to intervention and delayed intervention conditions. This article reports on the 27 families in the delayed intervention group. Families received up to 10 home visits over 10 months from a family advisor and completed activities to improve their dietary and physical activity behaviors. Coaching conversations took place during each home visit. Coaching process outcomes were evaluated by analysis of visit documentation, participant survey, and qualitative interviews. Results indicated that coaching, in conjunction with family activities, engaged families in the process of change and facilitated movement toward the achievement of their weekly nutrition or physical activity goals. Coaching methodology may be particularly useful for participatory research.

Prevention for Substance-Using HIV-Positive Young People

HIV risky behaviors and health practices were examined among young people living with HIV (YPLH) in Los Angeles, San Francisco, and New York over 15 months in response to receiving a preventive intervention. YPLH aged 16 to 29 years (n = 175; 26% black and 42% Latino; 69% gay men) were randomly assigned to a 3-module intervention totaling 18 sessions delivered by telephone, in person, or a delayed-intervention condition. Intention-to-treat analyses found that the in-person intervention resulted in a significantly higher proportion of sexual acts protected by condoms overall and with HIV-seronegative partners. Pre- and postanalyses of YPLH in the delayed-intervention condition alone found that YPLH tended to have fewer sexual partners, used fewer drugs, reported less emotional distress, and decreased their use of antiretroviral therapies. Prevention programs can be delivered in alternative formats while retaining efficacy. When YPLH are using hard drugs, drug treatment may be needed before delivery of preventive interventions.

Effects of a Tailored Health Promotion Program for Female Blue-Collar Workers: Health Works for Women

Background. This study assessed the effects of the Health Works for Women (HWW) intervention on improving multiple behaviors including nutrition and physical activity among rural female blue-collar employees in North Carolina.Methods. Nine small to mid-size workplaces were randomly assigned to either intervention or delayed intervention conditions. After a baseline survey, an intervention consisting of two computer-tailored magazines and a natural helpers program was conducted over 18 months. Delayed worksites received one tailored magazine. Approximately 77 and 76% of baseline respondents completed follow-up surveys at 6 and 18 months, respectively, and 538 women (63%) completed all three surveys.Results. At the 18-month follow-up, the intervention group had increased fruit and vegetable consumption by 0.7 daily servings compared to no change in the delayed group (P < 0.05). Significant differences in fat intake were observed at 6 months (P < 0.05) but not at 18 months. The intervention group also demonstrated improvements in strengthening and flexibility exercise compared to the delayed group. The rates of smoking cessation and cancer screening did not differ between study groups.Conclusions. The HWW project was a successful model for achieving certain health behavior changes among blue-collar women.

Take heart: results from the initial phase of a work-site wellness program.

The purpose of this study was to evaluate the short-term effects of a low-intensity work-site heart disease risk reduction program using a matched pair design with work site as the unit of analysis. Twenty-six heterogeneous work sites with between 125 and 750 employees were matched on key organization characteristics and then randomly assigned to early or delayed intervention conditions. Early intervention consisted of an 18-month multifaceted program that featured an employee steering committee and a menu approach to conducting key intervention activities tailored to each site. Cross-sectional and cohort analyses produced consistent results. At the conclusion of the intervention, early and delayed intervention conditions did not differ on changes in smoking rates, dietary intake, or cholesterol levels. There was considerable variability in outcomes among work sites within each condition. Despite documented implementation of key intervention activities and organization-level changes in terms of perceived support for health promotion, this intervention did not produce short-term improvements beyond secular trends observed in control work sites. Research is needed to understand determinants of variability between work sites.

Improving self-care among older patients with type II diabetes: The “sixty something…” Study

A 10-session, self-management training program was designed specifically for persons over 60 years of age having Type II diabetes. It targeted social learning variables, especially problem-solving skills and self-efficacy, found to be related to diabetes self care in earlier correlational research. One hundred two adults were randomized to immediate or delayed intervention conditions. At posttest, subjects in the immediate intervention condition showed significantly greater reductions in caloric intake and percent of calories from fat than control subjects. The intervention also produced greater weight reductions and increases in the frequency of glucose testing than did the control condition. Improvements among immediate intervention subjects were generally maintained at a 6-month follow-up. Intervention results from subjects receiving delayed intervention closely replicated those for immediate intervention subjects. We conclude that a relatively short-term program can improve self-management skills of older diabetic adults, and that there is an important need for such interventions.

A Multicommunity Trial for Primary Prevention of Adolescent Drug Abuse

The entire early adolescent population of the 15 communities that constitute the Kansas City (Kansas and Missouri) metropolitan area has participated in a community-based program for prevention of drug abuse since September 1984. The Kansas City area is the first of two major metropolitan sites being evaluated in the Midwestern Prevention Project, a longitudinal trial for primary prevention of cigarette, alcohol, and marijuana use in adolescents. The project includes mass media programming, a school-based educational program for youths, parent education and organization, community organization, and health policy components that are introduced sequentially into communities during a 6-year period. Effects of the program are determined through annual assessments of adolescent drug use in schools that are assigned to immediate intervention or delayed intervention control conditions. In the first 2 years of the project, 22,500 sixth- and seventh-grade adolescents received the school-based educational program component, with parental involvement in homework and mass media coverage. Analyses of 42 schools indicate that the prevalence rates of use for all three drugs are significantly lower at 1-year follow-up in the intervention condition relative to the delayed intervention condition, with or without controlling for race, grade, socioeconomic status, and urbanicity (17% vs 24% for cigarette smoking, 11% vs 16% for alcohol use, and 7% vs 10% for marijuana use in the last month), and the net increase in drug use prevalence among intervention schools is half that of delayed intervention schools.