WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial.
ABSTRACT: Background:Development disorders and delays are recognised as a public health priority and included in the WHO mental health gap action programme (mhGAP). Parents Skills Training (PST) is recommended as a key intervention for such conditions under the WHO mhGAP intervention guide. However, sustainable and scalable delivery of such evidence based interventions remains a challenge. This study aims to evaluate the effectiveness and scaled-up implementation of locally adapted WHO PST programme delivered by family volunteers in rural Pakistan. Methods:The study is a two arm single-blind effectiveness implementation-hybrid cluster randomised controlled trial. WHO PST programme will be delivered by 'family volunteers' to the caregivers of children with developmental disorders and delays in community-based settings. The intervention consists of the WHO PST along with the WHO mhGAP intervention for developmental disorders adapted for delivery using the android application on a tablet device. A total of 540 parent-child dyads will be recruited from 30 clusters. The primary outcome is child's functioning, measured by WHO Disability Assessment Schedule - child version (WHODAS-Child) at 6 months post intervention. Secondary outcomes include children's social communication and joint engagement with their caregiver, social emotional well-being, parental health related quality of life, family empowerment and stigmatizing experiences. Mixed method will be used to collect data on implementation outcomes. Trial has been retrospectively registered at ClinicalTrials.gov (NCT02792894). Discussion:This study addresses implementation challenges in the real world by incorporating evidence-based intervention strategies with social, technological and business innovations. If proven effective, the study will contribute to scaled-up implementation of evidence-based packages for public mental health in low resource settings. Trial registration:Registered with ClinicalTrials.gov as Family Networks (FaNs) for Children with Developmental Disorders and Delays. Identifier: NCT02792894 Registered on 6 July 2016.
Project description:<h4>Background</h4>There is a growing global need for scalable approaches to training and supervising primary care workers (PCWs) to deliver mental health services. Over the past decade, the World Health Organization Mental Health Gap Action Programme Intervention Guide (mhGAP-IG) and associated training and implementation guidance have been disseminated to more than 100 countries. On the basis of the opportunities provided by mobile technology, an updated electronic Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG) is now being developed along with a clinical dashboard and guidance for the use of mobile technology in supervision.<h4>Objective</h4>This study aims to assess the feasibility, acceptability, adoption, and other implementation parameters of the e-mhGAP-IG for diagnosis and management of depression in 2 lower-middle-income countries (Nepal and Nigeria) and to conduct a feasibility cluster randomized controlled trial (cRCT) to evaluate trial procedures for a subsequent fully powered trial comparing the clinical effectiveness and cost-effectiveness of the e-mhGAP-IG and remote supervision with standard mhGAP-IG implementation.<h4>Methods</h4>A feasibility cRCT will be conducted in Nepal and Nigeria to evaluate the feasibility of the e-mhGAP-IG for use in depression diagnosis and treatment. In each country, an estimated 20 primary health clinics (PHCs) in Nepal and 6 PHCs in Nigeria will be randomized to have their staff trained in e-mhGAP-IG or the paper version of mhGAP-IG v2.0. The PHC will be the unit of clustering. All PCWs within a facility will receive the same training (e-mhGAP-IG vs paper mhGAP-IG). Approximately 2-5 PCWs, depending on staffing, will be recruited per clinic (estimated 20 health workers per arm in Nepal and 15 per arm in Nigeria). The primary outcomes of interest will be the feasibility and acceptability of training, supervision, and care delivery using the e-mhGAP-IG. Secondary implementation outcomes include the adoption of the e-mhGAP-IG and feasibility of trial procedures. The secondary intervention outcome-and the primary outcome for a subsequent fully powered trial-will be the accurate identification of depression by PCWs. Detection rates before and after training will be compared in each arm.<h4>Results</h4>To date, qualitative formative work has been conducted at both sites to prepare for the pilot feasibility cRCT, and the e-mhGAP-IG and remote supervision guidelines have been developed.<h4>Conclusions</h4>The incorporation of mobile digital technology has the potential to improve the scalability of mental health services in primary care and enhance the quality and accuracy of care.<h4>Trial registration</h4>ClinicalTrials.gov NCT04522453; https://clinicaltrials.gov/ct2/show/NCT04522453.<h4>International registered report identifier (irrid)</h4>PRR1-10.2196/24115.
Project description:In 2002, WHO launched the Mental Health Gap Action Programme (mhGAP) as a strategy to help member states scale up services to address the growing burden of mental, neurological and substance use disorders globally, especially in countries with limited resources. Since then, the mhGAP program has been widely implemented but also criticised for insufficient attention to cultural and social context and ethical issues. To address this issue and help overcome related barriers to scale-up, we outline a framework of questions exploring key cultural and ethical dimensions of mhGAP planning, adaptation, training, and implementation. This framework is meant to guide mhGAP activity taking place around the world. Our approach is informed by recent research on cultural formulation and adaptation, and aligned with key components of the WHO implementation research guide (Peters, D. H., Tran, N. T., & Adam, T. (2013). Implementation research in health: a practical guide. Implementation research in health: a practical guide.). The framework covers three broad domains: (1) Concepts of wellness and illness-how to examine cultural norms, knowledge, values and attitudes in relation to the "culture of the mhGAP"; (2) Systems of care-identifying formal and informal systems of care in the cultural context of practice.; and (3) Ethical space: examining issues related to power dynamics, communication, and decision-making. Systematic consideration of these issues can guide integration of cultural knowledge, structural competence, and ethics in implementation efforts.
Project description:<h4>Background</h4>Globally, there is a large documented gap between needs of families and children with developmental disorders and available services. We adapted the World Health Organization's mental health Gap-Intervention Guidelines (mhGAP-IG) developmental disorders module into a tablet-based android application to train caregivers of children with developmental disorders. We aimed to evaluate the effectiveness of this technology-assisted, family volunteers delivered, parents' skills training intervention to improve functioning in children with developmental disorders in a rural community of Rawalpindi, Pakistan.<h4>Methods</h4>In a single-blinded, cluster randomized controlled trial, 30 clusters were randomised (1:1 ratio) to intervention (n = 15) or enhanced treatment as usual (ETAU) arm (n = 15). After screening, 540 children (18 participants per cluster) aged 2-12 years, with developmental disorders and their primary caregivers were recruited into the trial. Primary outcome was child's functioning, measured by Childhood Disability Assessment Schedule for Developmental Disorders (DD-CDAS) at 6-months post-intervention. Secondary outcomes were parents' health related quality of life, caregiver-child joint engagement, socio-emotional well-being of children, family empowerment and stigmatizing experiences. Intention-to-treat analyses were done using mixed-models adjusted for covariates and clusters.<h4>Results</h4>At 6-months post-intervention, no statistically significant mean difference was observed on DD-CDAS between intervention and ETAU (mean [SD], 47.65 [26.94] vs. 48.72 [28.37], Adjusted Mean Difference (AMD), - 2.63; 95% CI - 6.50 to 1.24). However, parents in the intervention arm, compared to ETAU reported improved health related quality of life (mean [SD] 65.56 [23.25] vs. 62.17 [22.63], AMD 5.28; 95% CI 0.44 to 10.11). The results were non-significant for other secondary outcomes.<h4>Conclusions</h4>In the relatively short intervention period of 6 months, no improvement in child functioning was observed; but, there were significant improvements in caregivers' health related quality of life. Further trials with a longer follow-up are recommended to evaluate the impact of intervention. Trial registration Clinicaltrials.gov, NCT02792894. Registered April 4, 2016, https://clinicaltrials.gov/ct2/show/NCT02792894.
Project description:<h4>Background</h4>The World Health Organization (WHO)'s Mental Health Gap Action Programme (mhGAP)-Intervention Guide (IG) aims to integrate mental health into primary care/community-based settings by equipping non-specialists with tools, training, and support to deliver evidence-based interventions. With the growing popularity of the mhGAP-IG, a systematic review was conducted by Keynejad and colleagues (2018) to identify articles reporting on evidence generated from the implementation and evaluation of the mhGAP-IG in low- and middle-income countries (LMICs). Their review identified peer-reviewed articles and one thesis. In this current review, we report on the implementation and use of mhGAP-IG documented in the grey literature, an important and accessible channel to share information for LMICs.<h4>Methods</h4>We searched grey literature databases for documents that reported on the implementation and/or use of the mhGAP-IG or its training modules: ProQuest Dissertations & Theses Global, the Mental Health Innovation Network (MHIN) database, the WHO website, the mhGAP Newsletter, and the first 10 pages of Google search results. Authors developed and adapted search strategies according to database characteristics. Database searches were completed by November 12, 2019.<h4>Results</h4>One hundred and fifty-one (n = 151) documents were included in our review. We report on where the mhGAP-IG has been implemented and/or used worldwide. Many types of personnel were trained in the mhGAP-IG and/or used it in clinical practice. Contextual barriers and facilitators may influence the implementation and/or use of the mhGAP-IG, and we organized these according to structural, organizational, provider, patient, and innovation characteristics. Some information on evaluating the mhGAP-IG was documented in the grey literature. Outcomes included: feasibility of implementing and/or using the mhGAP-IG, its coverage, its impact on the capacities of personnel, patient outcomes, and policies, as well as program costs.<h4>Conclusions</h4>This review of the grey literature provides rich experiential knowledge that can complement information documented in the peer-reviewed literature. It is important for researchers conducting reviews on global health/global mental health topics to consider incorporating grey literature search strategies in their reviews. This may not only help to acknowledge the research/dissemination realities of many LMICs, but also to generate findings that reinforce and/or expand those documented in peer-reviewed articles.
Project description:<h4>Background</h4>Parental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes. Family Talk is one of the better known interventions designed to prevent the intergenerational transmission of mental illness. However, its evidence base is small, with few robust independent randomised controlled trials, and no associated process or cost evaluations. The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed method evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness.<h4>Methods</h4>The study comprises a multi-centre, randomised controlled trial (RCT), with nested economic and process evaluations, to assess the clinical and cost-effectiveness and implementation mechanisms of Family Talk compared to usual services. The study is being conducted in 15 adult and child mental health settings in Ireland. Families with a parent with mental illness, and children aged 5-18 years (n = 144 families) will be randomised to either the 7-session Family Talk programme (n = 96) or to standard care (n = 48) using a 2:1 allocation ratio. The primary outcomes are child psychosocial functioning and family functioning. Secondary outcomes are as follows: understanding and experience of parental mental illness, parental mental health, child and parental resilience, partner wellbeing and service utilisation. Blind assessments will take place at pre-intervention and at 6- and 12-month follow-up.<h4>Discussion</h4>Given the prevalence and burden of intergenerational mental illness, it is imperative that prevention through evidence-based interventions becomes a public health priority. The current study will provide an important contribution to the international evidence base for Family Talk whilst also helping to identify key implementation lessons in the scaling up of Family Talk, and other similar interventions, within routine mental health settings.<h4>Trial registration</h4>ISRCTN Registry, ISRCTN13365858 . Registered 5th February 2019.
Project description:<h4>Background</h4>Inadequacy in mental health care in low and middle income countries has been an important contributor to the rising global burden of disease. The treatment gap is salient in resource-poor settings, especially when providing care for conflict-affected forced migrant populations. Primary care is often the only available service option for the majority of forced migrants, and integration of mental health into primary care is a difficult task. The proposed pilot study aims to explore the feasibility of integrating mental health care into primary care by providing training to primary care practitioners serving displaced populations, in order to improve identification, treatment, and referral of patients with common mental disorders via the World Health Organization Mental Health Gap Action Programme (mhGAP).<h4>Methods/design</h4>This pilot randomized controlled trial will recruit 86 primary care practitioners (PCP) serving in the Puttalam and Mannar districts of Sri Lanka (with displaced and returning conflict-affected populations). The intervention arm will receive a structured training program based on the mhGAP intervention guide. Primary outcomes will be rates of correct identification, adequate management based on set criteria, and correct referrals of common mental disorders. A qualitative study exploring the attitudes, views, and perspectives of PCP on integrating mental health and primary care will be nested within the pilot study. An economic evaluation will be carried out by gathering service utilization information.<h4>Discussion</h4>In post-conflict Sri Lanka, an important need exists to provide adequate mental health care to conflict-affected internally displaced persons who are returning to their areas of origin after prolonged displacement. The proposed study will act as a local demonstration project, exploring the feasibility of formulating a larger-scale intervention study in the future, and is envisaged to provide information on engaging PCP, and data on training and evaluation including economic costs, patient recruitment, and acceptance and follow-up rates. The study should provide important information on the WHO mhGAP intervention guide to add to the growing evidence base of its implementation.<h4>Trial registration</h4>SLCTR/2013/025.
Project description:<h4>Introduction</h4>Early intervention (EI) endorses family-centred and participation-focused services, but there remain insufficient options for systematically enacting this service approach. The Young Children's Participation and Environment Measure electronic patient-reported outcome (YC-PEM e-PRO) is an evidence-based measure for caregivers that enables family-centred services in EI. The Parent-Reported Outcomes for Strengthening Partnership within the Early Intervention Care Team (PROSPECT) is a community-based pragmatic trial examining the effectiveness of implementing the YC-PEM e-PRO measure and decision support tool as an option for use within routine EI care, on service quality and child outcomes (aim 1). Following trial completion, we will characterise stakeholder perspectives of facilitators and barriers to its implementation across multiple EI programmes (aim 2).<h4>Methods and analysis</h4>This study employs a hybrid type 1 effectiveness-implementation study design. For aim 1, we aim to enrol 223 caregivers of children with or at risk for developmental disabilities or delays aged 0-3 years old that have accessed EI services for three or more months from one EI programme in the Denver Metro catchment of Colorado. Participants will be invited to enrol for 12 months, beginning at the time of their child's annual evaluation of progress. Participants will be randomised using a cluster-randomised design at the EI service coordinator level. Both groups will complete baseline testing and follow-up assessment at 1, 6 and 12 months. A generalised linear mixed model will be fitted for each outcome of interest, with group, time and their interactions as primary fixed effects, and adjusting for child age and condition severity as secondary fixed effects. For aim 2, we will conduct focus groups with EI stakeholders (families in the intervention group, service coordinators and other service providers in the EI programme, and programme leadership) which will be analysed thematically to explain aim 1 results and identify supports and remaining barriers to its broader implementation in multiple EI programmes.<h4>Ethics and dissemination</h4>This study has been approved by the institutional review boards at the University of Illinois at Chicago (2020-0555) and University of Colorado (20-2380). An active dissemination plan will ensure that findings have maximum reach for research and practice.<h4>Trial registration number</h4>NCT04562038.
Project description:Background:Integrating child and adolescent mental health (CAMH) into primary health care (PHC) using the WHO mental health gap action program (mhGAP) is recommended for closing a mental health treatment gap in low- and middle-income countries, but PHC providers have limited ability to detect CAMH disorders. We aimed to evaluate the effect of PHC provider mhGAP training on CAMH disorder identification in Eastern Uganda. Methods:Thirty-six PHC clinics participated in a randomized controlled trial which compared the proportion of intervention (n = 18) to control (n = 18) clinics with a non-epilepsy CAMH diagnosis over 3 consecutive months following mhGAP-oriented CAMH training. Fisher's exact test and logistic regression based on intention to treat principles were applied. (clinicaltrials.gov registration NCT02552056). Results:Nearly two thirds (63.8%, 23/36) of all clinics identified and recorded at least one non-epilepsy CAMH diagnosis from 40 692 clinic visits of patients aged 1-18 recorded over 4 months. The proportion of clinics with a non-epilepsy CAMH diagnosis prior to training was 27.7% (10/36, similar between study arms). Training did not significantly improve intervention clinics' non-epilepsy CAMH diagnosis (13/18, 72.2%) relative to the control (7/18, 38.9%) arm, p = 0.092. The odds of identifying and recording a non-epilepsy CAMH diagnosis were 2.5 times higher in the intervention than control arms at the end of 3 months of follow-up [adj.OR 2.48; 95% CI (1.31-4.68); p = 0.005]. Conclusion:In this setting, mhGAP CAMH training of PHC providers increases PHC clinics' identification and reporting of non-epilepsy CAMH cases but this increase did not reach statistical significance.
Project description:<h4>Background</h4>Early identification and management of child and adolescent mental health (CAMH) disorders helps to avert mental illness in adulthood but a CAMH treatment gap exists in Uganda. CAMH integration into primary health care (PHC) through in-service training of non-specialist health workers (NSHW) using the World Health Organisation (WHO) Mental Health Gap Action Programme (mhGAP) Intervention Guide (IG) is a strategy to address this gap. However, results of such training are not supported by information on training development or delivery; and are undifferentiated by NSHW cadre. We aim to describe an in-service CAMH training for NSHW in Uganda and assess cadre-differentiated learning outcomes.<h4>Methods</h4>Thirty-six clinical officers, nurses and midwives from 18 randomly selected PHC clinics in eastern Uganda were trained for 5 days on CAMH screening and referral using a curriculum based on the mhGAP-IG version 1.0 and PowerPoint slides from the International Association of Child and Adolescent Psychiatry and Allied Professions (IACAPAP). The residential training was evaluated through pre- and post- training tests of CAMH knowledge and attitudes using the participants' post-test scores; and the difference between pre-test and post-test scores. Two-tailed t-tests assessed differences in mean pre-test and post-test scores between the cadres; hierarchical linear regression tested the association between cadre and post test scores; and logistic regression evaluated the relationship between cadre and knowledge gain at three pre-determined cut off points.<h4>Results</h4>Thirty-three participants completed both pre-and post-tests. Improved mean scores from pre- to post-test were observed for both clinical officers (20% change) and nurse/midwives (18% change). Clinical officers had significantly higher mean test scores than nurses and midwives (p < 0.05) but cadre was not significantly associated with improvement in CAMH knowledge at the 10% (AOR 0.08; 95 CI [0.01, 1.19]; p = 0.066), 15% (AOR 0.16; 95% CI [0.01, 2.21]; p = 0.170), or 25% (AOR 0.13; 95% CI [0.01, 1.74]; p = 0.122) levels.<h4>Conclusion</h4>We aimed to examine CAMH learning outcomes by NSHW cadre. NSHW cadre does not influence knowledge gain from in-service CAMH training. Thus, an option for integrating CAMH into PHC in Uganda using the mhGAP-IG and IACAPAP PowerPoint slides is to proceed without cadre differentiation.
Project description:The Zika virus outbreak in Brazil in 2015 affected thousands of people. Zika is now known to cause congenital malformations leading to impairments and developmental delays in affected children, including Congenital Zika Syndrome (CZS). Children with CZS have complex care needs. Caregivers require significant levels of support to meet these needs, and there are large gaps in healthcare services. This study aims to develop, pilot and assess the feasibility and scalability of a community-based Family Support Programme for caregivers of children with CZS. The programme is adapted from the Getting to Know Cerebral Palsy (GTKCP) programme for the context of CZS in Brazil. GTKCP is a 10-session programme held with 6-10 caregivers in the local community. It includes practical, educational, peer-support and psychosocial aspects, which aim to improve confidence and capacity to care for a child with CP, and quality of life and empowerment of caregivers. The research project contains four components: Ascertaining need for the caregiver programme: a mixed-methods approach that included two literature reviews, interviews with key stakeholders in country, and incorporation of findings from the Social and Economic Impact of Zika study.Adapting GTKCP for the context of CZS and Brazil: undertaken with guidance from technical experts.Pilot testing the intervention: deliver the 10-session programme to one group of caregivers of children with CZS in Rio de Janeiro and another in Greater Salvador.Update the manual through fast-track learning from participant and facilitator feedback. Assessing the feasibility of the intervention for scale up: deliver the updated programme to two groups each in Rio de Janeiro and Greater Salvador, and evaluate the acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited efficacy, through questionnaires, direct observation, semi-structured interviews and cost calculation. The project has ethics approval in both the UK and Brazil.