Enhance Child Development Research Articles

Making connections matter: Enhancing child development through online parenting interventions.

Making connections matter: Enhancing child development through online parenting interventions.

Evaluating the effectiveness of a Portage program on reducing parenting stress and enhancing child development in autism spectrum disorders

BackgroundAutism spectrum disorder (ASD) manifests in early childhood and significantly impairs social and communicative functions. Parents of children with ASD typically experience higher levels of stress compared to parents of children with other disabilities or health issues. This study investigates how a home-based early intervention known as the Portage program influences parenting stress and improves family awareness by using the Parental Stress Scale (PSS), and Family Awareness Scale. We enrolled 41 children diagnosed with ASD and their parents in this study. The median age of the children was 4 years, with a predominance of males (80%). We measured changes in parenting stress and family awareness as primary outcomes, with the children’s behavior as a secondary outcome.ResultsPost-intervention assessments showed statistically significant improvements in parenting stress and family awareness (P < 0.001). Additionally, notable improvements were observed in the children’s social, language, self-help, cognitive, and motor skills, as well as general developmental age and ratio.ConclusionsA 3-month engagement with the Portage program markedly reduced stress among parents and increased family awareness regarding ASD. Significant advancements were also noted in multiple developmental domains of the children involved.

Randomized controlled trial of the parents as teacher home visiting program: Outcomes of the intervention on families at six month follow-up

Family support programs are considered central to improving the health and development of children, and home visitation remains one of the most frequently used early intervention strategies. This study utilized a randomized controlled trial (RCT) design to test the effectiveness of the Parents as Teachers (PAT) home visiting program intervention on child and caregiver outcomes, measured at six months post enrollment, with families randomized to study groups. Four PAT affiliates selected for the study are “blue ribbon” programs that meet certain quality standards. A total of 461 families (a 69 % retention rate) completed both baseline and 6-month data collection, including n = 295 for intervention and n = 166 for control. Differential attrition was 3.7 %. Baseline equivalency tests confirmed that the random assignment was effective and the groups were equivalent. Significant differences were observed between intervention and control groups, favoring the PAT intervention group, in 3 of the 4 domains assessed: child development, including Vineland-II Listening and Understanding and Talking and frequency of reading to the child; parenting practices, including improved sense of parenting efficacy and hopefulness; and family health and safety, including improved safety practices at home and reduced risk scores that capture depression and parenting stress. Estimated effect sizes for significant measures ranged from 0.12 to 0.28 and thus were in the range of what would be considered to have meaningful impact when compared with similar studies. Our findings contribute significantly to the understanding of home visitation program outcomes and adds to existing research by showing gains in child development that can be attributed to the PAT program. The RCT provides valuable evidence supporting the PAT program’s role in enhancing child development, improving parenting practices, and ensuring family health and safety. However, the lack of difference in service utilization between groups and the challenges faced during the study highlight the need for consideration of external factors, such as the impact of the COVID-19 pandemic on service availability and utilization. This study contributes to the broader understanding of early childhood interventions and their efficacy in real-world, community settings.

Understanding modifiable caregiver factors contributing to child development among young children in rural Malawi.

This study examined modifiable caregiver factors influencing child development in Malawi using baseline data from 1,021 mothers and their children <2 years of age participating in a cluster-randomized controlled trial implemented in rural Malawi (2022-2025). We fit an evidence-based theoretical model using structural equation modelling examining four caregiver factors: (1) diet diversity (sum of food groups consumed in the past 24 h), (2) empowerment (assessed using the project-level Women's Empowerment in Agriculture Index), (3) mental health (assessed using the Self-Reported Questionnaire, SRQ-20), and (4) stimulation (number of stimulation activities the mother engaged in the past 3 days). Child development was assessed using the Malawi Development Assessment Tool (norm-referenced aggregate Z-score). The model controlled for child, caregiver, and household socioeconomic characteristics. Results showed that caregiver dietary diversity was directly associated with higher child development scores (standardized coefficient 0.091 [95% CI 0.027, 0.153]) and lower SRQ-20 scores -0.058 (-0.111, -0.006). Empowerment was directly associated with higher child development scores (0.071 [0.007, 0.133]), higher stimulation score (0.074 [0.013, 0.140]), higher dietary diversity (0.085 [0.016, 0.145]), and lower SRQ-20 scores (-0.068 [-0.137, -0.002]). Further, higher empowerment was indirectly associated with improved child development through enhancement of caregiver dietary diversity, with an indirect effect of 0.008 (0.002, 0.018). These findings highlight the important role that caregiver diet and empowerment play in directly influencing child development and other aspects of caregiver well-being. Interventions aimed at enhancing child development should consider these factors as potential targets to improve outcomes for children and caregivers.

Ruhiyah Attachment: Integrating Spirituality into Attachment Theory for Enhanced Child Development

Purpose – This article aims to introduce a new perspective in attachment theory called ruhiyah attachment. Ruhiyah attachment emphasizes the role of caregivers as mediators to connect children spiritually with Allah SWT, proposing this spiritual connection as a potential solution to the mental health crisis among teenagers. Design/methods/approach – This paper employs a literature research methodology. The research involves (1) selecting the topic, (2) searching academic databases for relevant articles and journals, (3) collecting data from primary sources (articles and books on attachment theory) and secondary sources (application and implementation studies), (4) analyzing literature to identify patterns, themes, or differences across ten sources, (5) presenting findings, and (6) conducting a critical assessment of ruhiyah attachment as a new perspective in attachment studies. Findings – The research presents ruhiyah attachment as a new perspective in child attachment studies. It emphasizes that spiritual attachment, facilitated by caregivers as mediators, is crucial for children's development. Ruhiyah attachment extends beyond the mother-child bond to include a spiritual connection with the Creator, potentially addressing mental health crises by fostering a strong spiritual foundation in children. Research implications/limitations – This research broadens the discourse on child attachment studies. The literature review methodology allows a comprehensive examination of various perspectives in attachment research. Ruhiyah attachment offers a new viewpoint that may stimulate future studies. Limitations include the reliance on secondary sources and the need for empirical validation of the proposed perspective. Practical implications – Ruhiyah attachment can enhance early childhood education and care by integrating spirituality into attachment theory. This perspective allows children to develop a direct spiritual connection with Allah SWT through their bond with caregivers, promoting long-term mental and spiritual well-being. It suggests that spiritual strength can help prevent mental health crises and encourage moral development. Originality/value – This research introduces a spiritual dimension to child attachment studies, addressing the mental health crisis by proposing ruhiyah attachment as a novel perspective. Paper type Literature review

Investigating the Child Development of Learners with Special Educational Needs in Inclusive Education

Abstract: This study examined the development of 22 learners with special educational needs (LSENs) in inclusive education at Balamban SPED Center Elementary School in the Philippines. Surveys were used for data collection, and the analysis included descriptive statistics and comparative analysis. Most participants were 5-12-year-old females with three or four siblings. Their families had a monthly income of Php 10,000 or below. Autism was the most common particular need among successful learners, followed by hearing impairment and intellectual disability. According to parents, LSENs exhibited well-developed knowledge, attitude, skills, and behavior. Teachers, however, perceived that only knowledge and behavior were well-developed, while attitudes and skills showed moderate development. Perceptions of parents and teachers regarding child development did not differ significantly. The study concluded that inclusive education plays a crucial role in the success and development of LSENs. Successful learners demonstrated high levels of knowledge and behavior, as assessed by both parents and teachers. Teachers rated attitudes and skills as moderately developed. LSENs achieved functional literacy and adaptive behaviors necessary for daily life and prospects. Collaboration between parents and teachers was emphasized for enhancing child development and fostering holistic learners at home, school, and community. The study recommends that administrators use the findings to develop appropriate programs for LSENs, while teachers and parents utilize the results as an action plan to address educational gaps. The study can serve as a baseline for future research on the benefits of inclusive education for LSENs.

Surveillance and monitoring program of child neurodevelopment in population born during social confinement due to covid contigence: monteria-colombia experience

IntroductionThe American Academy of Pediatrics reports an incidence of 1 in every 54 children (Council on Children with Disabilities, 2021). The unique circumstances surrounding children born in 2020, who have experienced the COVID-19 pandemic since birth, present a distinct set of challenges for their neurodevelopmental well-being. The pandemic has led to reduced opportunities for learning and social interaction, masking mandates, decreased social support for research, and the potential misattribution of Autism Spectrum Disorders ASD symptoms to the effects of social isolation.ObjectivesThis study aims to develop such a program for children born during the COVID-19 pandemic (2020-2022).MethodsAll children born in March 2020 were included in the study. The initial assessment involved administering the ASQ-3 to evaluate their development across the specified domains. Diagnostic Evaluation: Among the population, 6% (4 children) displayed concerning signs on the ASQ-3, warranting further diagnostic evaluation by specialized health professionals for possible ASD.ResultsEarly Intervention and School Monitoring: Of the remaining 72% (46 children), who did not require diagnostic evaluation, intervention guidelines were provided, both within the school environment and at home. These children were reevaluated after a three-month period. Follow-up in the School Environment: Those children who underwent reevaluation were categorized into three groups: Nine children fell into the “gray” category on the ASQ-3 and were subsequently referred for diagnostic evaluation. Thirty-seven children progressed to the “white” category on the ASQ-3 after receiving intervention guidelines in both school and home settings. The findings of this research underscore the potential impact of the COVID-19 pandemic on the neurodevelopment of children born in 2020. 6% of the evaluated population were referred for diagnostic evaluation due to signs of ASD, suggesting a potential association between the pandemic and an increased risk of ASD within this cohort.72% of children who received intervention guidelines demonstrated significant improvements in their neurodevelopment, highlighting the critical role of early intervention and school-based monitoringConclusionsImplementing support strategies within educational settings was linked to positive developments in neurodevelopmental outcomes. Consequently, school-based neurodevelopmental monitoring, complemented by cohesive curricular guidelines, emerges as a beneficial approach for enhancing child development outcomes. The ASQ-3, as a structured instrument, proves invaluable in facilitating neurodevelopmental surveillance within educational settings, particularly in contexts with high demand and limited access to specialized care.Disclosure of InterestNone Declared

Assessing the influence of COVID-19 lockdown measures on cognition and behavior in school age children in Arba Minch Health and Demographic Surveillance site, Southern Ethiopia: A cross-sectional study.

Ethiopian schools were closed for nearly 40 weeks as a measure to control the COVID-19 pandemic. The objective of the study was to evaluate the role of COVID-19 pandemic's restrictive measures on cognition and behavioral difficulties of schoolchildren in Arba Minch Health and Demographic Surveillance Site. Two cross-sectional surveys were conducted in November 2019 (pre-COVID-19-lockdown) and November 2020 (post-COVID-19 lockdown). Data were collected both at the school and homes of the children. Cognitive development of the children was assessed using digit span, Raven's coloured progressive matrices (RCPM) and Visual search using cancellation task. Behavioral difficulties score of the children was assessed using Strengths and Difficulties Questionnaire. Analysis of covariance (ANCOVA) was used to compare between the cognition outcomes and behavioral difficulties score pre- and post-COVID-19-lockdown. In a sub-group of children who provided data in both surveys, the difference in cognitive and behavioral outcomes was tested using a mixed effect model. Compared to the pre-COVID-19-lockdown, schoolchildren post-COVID-19-lockdown scored lower in the standardized performance index for the visual search task, which measures attention (0.27 SD, 95% confidence intervals (95%CI): -0.40, -0.13). However, they scored higher by 0.26 SD (95%CI: 0.13, 0.40) and 0.36 SD (95%CI: 0.22, 0.49) in digit span and RCPM, respectively, measuring working memory and non-verbal intelligence. There was no significant difference in total difficulties score between pre- and post-COVID-19-lockdown (0.01 SD, 95%CI: -0.12, 0.15). The subgroup analysis showed a significant increase in digit span among children post-COVID-19-lockdown while the other domains did not show a significant change. Factors contributing to the improvement of children's cognitive domains while away from the school environment should be explored and utilized to enhance child development. This study was registered at clinicaltrials.gov as NCT04137354 on October 14, 2019.

Basic Environmental Supports for Positive Brain and Cognitive Development in the First Year of Life

Defining basic psychosocial resources to facilitate thriving in the first year of life could tangibly inform policy and enhance child development worldwide. To determine if key environmental supports measured as a thrive factor (T-factor) in the first year of life positively impact brain, cognitive, and socioemotional outcomes through age 3. This prospective longitudinal cohort study took place at a Midwestern academic medical center from 2017 through 2022. Participants included singleton offspring oversampled for those facing poverty, without birth complications, congenital anomalies, or in utero substance exposures (except cigarettes and marijuana) ascertained prenatally and followed up prospectively for the first 3 years of life. Data were analyzed from March 9, 2023, through January 3, 2024. Varying levels of prenatal social disadvantage advantage and a T-factor composed of environmental stimulation, nutrition, neighborhood safety, positive caregiving, and child sleep. Gray and white matter brain volumes and cortical folding at ages 2 and 3 years, cognitive and language abilities at age 3 years measured by the Bayley-III, and internalizing and externalizing symptoms at age 2 years measured by the Infant-Toddler Social and Emotional Assessment. The T-factor was positively associated with child cognitive abilities (β = 0.33; 95% CI, 0.14-0.52), controlling key variables including prenatal social disadvantage (PSD) and maternal cognitive abilities. The T-factor was associated with child language (β = 0.36; 95% CI, 0.24-0.49), but not after covarying for PSD. The association of the T-factor with child cognitive and language abilities was moderated by PSD (β = -0.32; 95% CI, -0.48 to -0.15 and β = -0.36; 95% CI, -0.52 to -0.20, respectively). Increases in the T-factor were positively associated with these outcomes, but only for children at the mean and 1 SD below the mean of PSD. The T-factor was negatively associated with child externalizing and internalizing symptoms over and above PSD and other covariates (β = -0.30; 95% CI, -0.52 to -0.08 and β = -0.32; 95% CI, -0.55 to -0.09, respectively). Increasing T-factor scores were associated with decreases in internalizing symptoms, but only for children with PSD 1 SD above the mean. The T-factor was positively associated with child cortical gray matter above PSD and other covariates (β = 0.29; 95% CI, 0.04-0.54), with no interaction between PSD and T-factor. Findings from this study suggest that key aspects of the psychosocial environment in the first year impact critical developmental outcomes including cognitive, brain, and socioemotional development at age 3 years. This suggests that environmental resources and enhancement in the first year of life may facilitate every infant's ability to thrive, setting the stage for a more positive developmental trajectory.

The Role of Childcare Programs and Family Involvement in Enhancing Child Development in Pre-primary Schools in Iganga District, Uganda

The study sought to establish the role of childcare programs and family involvement in enhancing child development in pre-primary schools in Nakalama and Bumalamagi sub-counties of Iganga District, Uganda. The study was guided by the following objectives: How do childcare programs and family involvement support child development, the challenges hindering the role of childcare programs and family involvement in promoting child development in pre-primary schools, the strategies that can be used to overcome the challenges facing childcare programs in promoting child development and how can family involvement be enhanced in promoting child development in pre-primary schools in Iganga District. The study used descriptive survey design that included both quantitative and qualitative methods. Purposive and random sampling techniques were used to sample the 77 key respondents drawn from the district, sub-counties, and institutions. Specifically reviewed literature, observation, focus group discussion, and interviews were used during data collection. The findings revealed that childcare programs and family involvement help children develop physically, socially, intellectually, and spiritually. Some of the challenges hindering the role of childcare programs and family involvement in promoting child development were; Shortage of trained and qualified teachers in pre-primary schools and Lack of public awareness in enhancing child development. It is recommended that the government refocus its strategy on addressing the country's education crisis and confronting issues at the grassroots level and intensifying the training of Caregivers for Early Child Development programs including embarking on implementing ECD programs in all government aided primary schools.

Maternal postnatal depressive symptoms and early achievement of developmental milestones in infants and young children: A meta-analysis.

Screening for social determinants of health, including maternal depression, is a recommended pediatric practice. However, the magnitude of association between maternal and child screening tools remains to be determined. The current study evaluated the association between maternal postnatal depressive symptoms and child developmental milestones, as well as moderators of these associations. A comprehensive search strategy was carried out in four databases (MEDLINE, EMBASE, APA PsycINFO, and Cochrane Central Register of Controlled Trials) from database inception to September 2022. Studies that examine postnatal depressive symptoms and associations with infant and early child (<6 years) achievement of developmental milestones were included. Data were extracted by two independent coders and a random-effects meta-analysis was used to estimate pooled effect sizes and test for moderators. A total of 38 non-overlapping studies (95,897 participants), all focused on maternal postnatal depression, met inclusion criteria. The pooled effect size for the association between postnatal depressive symptoms and early achievement of infant and child developmental milestones (N=38; r=-.12; 95% CI=-.18, -.06) was small in magnitude. Child age at maternal depression measurement was a moderator, whereby effect sizes became greater for older children. Despite small effects, maternal postnatal depressive symptoms should be included in screening during routine well-child visits to enhance child development outcomes.

Extended maternity leave and children's long‐term development

AbstractCountries around the world are increasingly expanding legal maternity leaves, with the dual objective of protecting mothers' jobs during their recovery after childbirth and enhancing child development. Using exhaustive census data, we find that a three‐year paid leave in France had zero average effects on children's long‐term schooling achievement, and no detectable impact heterogeneity. The lack of positive effects on children adds to the case against a policy that has strong adverse effects on mothers' careers.

A pilot randomized control trial on the feasibility, acceptability, and initial effects of a digital-assisted parenting intervention for promoting mental health in Malaysian adolescents.

Online parenting interventions for enhancing child development, specifically mental health is relatively new in Malaysia. This pilot study tests the feasibility, acceptability, and initial effects of a universal digital-assisted parenting intervention (DaPI) in promoting mental health in adolescents by improving parental behaviors and self-efficacy. A two-arm pilot randomized controlled trial was conducted. Twenty-four mothers of adolescent aged 10 to 14 years from a non-clinical sample were recruited online and randomly allocated into two groups (intervention [DaPI] and waitlist-control [WLC]). Eight weekly sessions were delivered online via technological devices. Feasibility outcomes were based on the participants' engagement in DaPI and study retention. Primary (parental behaviors and self-efficacy) and secondary (adolescent mental health) outcomes were assessed using an online survey at baseline (T0), post-intervention (T1), and 1-month follow-up (T2). Data were analyzed using descriptive and inferential statistics and an intention-to-treat approach. The DaPI was well received by the mothers. Retention was high (81.8%) in both groups and intervention adherence was excellent (91.6%). Within-group analyses showed a significant decrease in physical control at T2 and an increase in parental self-efficacy at T1 and T2 among the DaPI mothers. No significant differences were observed in adolescents' mental health at any time point. As for the WLC group, there were no significant differences in all the outcome variables across the three assessment moments. Between groups analyses revealed DaPI mothers had significant differences in proactive parenting at T1, and in positive reinforcement and lax control at T2. There were no significant differences in adolescents' mental health between the groups at any time point. The DaPI is feasible and acceptable in the Malaysian context. Findings show promise regarding the initial effects of the DaPI. However, a larger RCT is needed to determine its effectiveness in promoting mental health of adolescents. https://www.irct.ir/; identifier: IRCT20211129053207N1.

Enhancing Child Development: Assessing the Impact of Monitoring Programs on Growth in Kendari City's Children Aged 6-59 Months

Growth serves as a crucial indicator of good nutritional status, attainable through adequate nutrition from an early age. Insufficient nutrition from the prenatal stage through birth can lead to various health issues that impede the growth and development of children. This study aims to analyze the effects of a monitoring program on toddler growth in Kendari City. Conducted between January and March 2023, this analytical observational study employed a cross-sectional design involving 120 respondents from the Benu-benua Health Center and Nambo Health Center in Kendari City, Southeast Sulawesi, Indonesia. The research data underwent processing and analysis using Chi-square tests and multiple linear regression. The findings revealed that knowledge, perceptions, family support, and the involvement of community health workers significantly impacted infant growth within the working areas of Puskesmas Benu-Benua and Puskesmas Nambo. Keywords: Influence, Monitoring, growth, Toddlers

Non-Intrusive Maternal Style as a Mediator between Playfulness and Children's Development for Low-Income Chilean Adolescent Mothers.

The aim of this study was to describe the relationship between low-income Chilean adolescent maternal playfulness and mothers' non-intrusiveness in their children's development and to analyze whether a mother's non-intrusiveness mediates the relationship between maternal playfulness and children's development. The Parental Playfulness Scale and the Subscale of Intrusiveness from the Early Head Start Research and Evaluation Project were used to assess maternal playfulness and mothers' non-intrusiveness respectively. Ages and Stages Questionnaire 3rd Edition (ASQ-3) was applied to measure the children's communication, gross and fine motor skills, problem-solving and personal-social development. The sample consisted of 79 mother-child dyads with children aged 10-24 months (M = 15.5, SD = 4.2) and their mothers aged 15-21 years old (M = 19.1, SD = 1.7). A bivariate analysis showed that maternal playfulness was significantly associated with communication, fine motor, problem-solving and personal-social development. Moreover, higher levels of communication, fine motor skills and problem-solving development were observed in the children of less intrusive mothers. Maternal playfulness had a significant effect on children's development of language, problem-solving and personal-social skills when their mothers showed less intrusiveness during interaction. These findings contribute to the understanding of the interaction between adolescent mothers and their children. Active play and less intrusiveness can enhance child development.

The Foundations for Chronic Low Back Pain Management may Start in Early Life. Exploring the Role of Caregiver Parental Leave on Future Low Back Pain in the Offspring

Chronic low back pain is difficult to treat and despite increased spending on health services, clinical outcomes for people with low back pain have not improved. Innovative, large scale initiatives seem necessary to stem the cost of low back pain. Psychological health contributes to the development and persistence of chronic low back pain and psychological interventions are important in the management of low back pain. Given the contribution of psychological health to low back pain development and management, it raises the question; can we support psychological health in later life by bolstering emotional development in early life, and reduce the burden of this common condition? Positive early life experiences, including those induced by extended paid parental leave, could bolster emotional development and support the psychological health necessary to manage low back pain in later life. We present the current state of evidence demonstrating the potential value of increasing support for parent-child relationships in early life to reduce the burden of low back pain in future generations. The current evidence is limited to cross-sectional associations, but strong preclinical data clearly shows the potential negative impacts of maternal separation on rodent pup health that compels consideration in human populations. PerspectiveThe benefits stemming from enhanced child development include stable emotional foundations, possibly improving psychological health and low back pain management in the future. This perspective raises questions for future studies – within the context of low back pain, what ingredients bolster stable psychological health? And are these ingredients influenced by parental leave?

The Effect of Maternal Responsive Interaction on Child Development: The Mediating Effect of Children’s Temperament and Interactive behavior

This study evaluates the relation of maternal responsive interaction on children's temperament and interactive behavior. Participants consisted of 95 mothers and their children dyads from the Seoul area and Gyeonggi Province. In this study, Analysis of Moment Structure (AMOS) was used to test the concordance of the combined equation structure model of approach that was theoretically appropriate to explain the process through which maternal interaction affect child's factors. The results are as follows. First, mother interaction had a negative correlation with children's temperament behavior, and a positive correlation with children's interactive behavior and child development was found. Second, maternal responsive interactions were effective in promoting child development by positively changing children's temperament behavior. Third, the maternal interaction promoted children's interactive behavior, and the child's capability of social interactive behavior enhanced child development. This study shows that the mother's responsive interaction enhanced child’s development through temperamental behavior and interactive behavior. Therefore, parent-child interaction should be considered important in the intervention practice to promote child’s developmental functions.

Determinants of noncognitive skills: Mediating effects of siblings' interaction and parenting quality

AbstractThis paper sheds light on the formation process of noncognitive skills by examining the determinants of a host of personality traits. Using data from the National Survey of Midlife Development in the United States (MIDUS), for individuals in larger families (three or more children), we find having a same‐sex sibling leads to improved long‐run noncognitive skills and positive personality traits. The latter result is driven entirely by females. We examine potential mechanisms by exploring the links between parental investment and sibling interactions. The results could possibly speak to public actions to enhance child development and human capital accumulation.

Child work and cognitive development: Results from four low to middle income countries

We study the impact of child work on cognitive development in four Low‐ and Middle‐Income Countries. We advance the literature by using cognitive test scores collected regardless of school attendance. We also address a key gap in the literature by controlling for children's complete time allocation budget. This allows us to estimate effects of different types of work, like chores and market/farm work, relative to specific alternative time‐uses, like school or study or play/leisure. Our results show child work is more detrimental to child development to the extent that it crowds out school/study time rather than leisure. We also show the adverse effect of time spent on domestic chores is similar to time spent on market and farm work, provided they both crowd out school/study time. Thus, policies to enhance child development should target a shift from all forms of work toward educational activities.

An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial

BackgroundThe combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experience perinatal depression. Perinatal depression is associated with negative effects on parenting and key domains of child development including cognitive, behavioural and growth, especially in socio-economically disadvantaged communities. Several studies have documented the benefits of psychological interventions for perinatal depression in low- and middle-income countries, but none have evaluated an integrated psychological and parenting intervention for HIV-positive women using task-sharing. This randomised controlled trial aims to evaluate the effect of a home-based intervention, combining a psychological treatment for depression and a parenting programme for perinatally depressed HIV-positive women.MethodsThis study is a cluster randomised controlled trial, consisting of 48–60 geospatial clusters. A total of 528 pregnant HIV-positive women aged ≥ 16 years who meet the criteria for depression on the Edinburgh Postnatal Depression Scale (EPDS, score ≥ 9)) are recruited from antenatal clinics in rural KwaZulu-Natal, South Africa. The geospatial clusters are randomised on an allocation ratio of 1:1 to either the intervention or Enhanced Standard of Care (ESoC). The intervention group receives 10 home-based counselling sessions by a lay counsellor (4 antenatal and 6 postnatal sessions) and a booster session at 16 months. The intervention combines behavioural activation for depression with a parenting programme, adapted from the UNICEF/WHO Care for Child Development programme. The ESoC group receives two antenatal and two postnatal counselling support and advice telephone calls.In addition, measures have been taken to enhance the routine standard of care.The co-primary outcomes are child cognitive development at 24 months assessed on the cognitive subscale of the Bayley Scales of Infant Development-Third Edition and maternal depression at 12 months measured by the EPDS.AnalysisThe primary analysis will be a modified intention-to-treat analysis. The primary outcomes will be analysed using mixed-effects linear regression.DiscussionIf this treatment is successful, policymakers could use this model of mental healthcare delivered by lay counsellors within HIV treatment programmes to provide more comprehensive services for families affected by HIV.Trial registrationISRCTN registry #11284870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).