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Numerous influential policy and scientific bodies are calling for more rapid advances in the scale-up of child and youth mental health services (CYMHS). A number of CYMHS innovations hold promise for advancing scale-up but little is known about how real-world efforts are progressing. We conducted a scoping review to identify promising approaches to CYMHS scale-up across the globe. Searches were completed in six databases (Academic Search Complete, CINAHL, MEDLINE, PsychInfo, PubMed, and Web of Science). Article selection and synthesis were conducted in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) checklist. A second search focused on low-and-middle-income countries (LMIC) was conducted based on the Cochrane Library recommended search filters of the World Bank listed LMIC countries. Authors used a double coding strategy during the title/abstract and full-text review. Twenty-eight articles meeting the eligibility criteria were identified that described 22 initiatives (in 11 different countries). Our review found the majority of published scale-up studies in CYMHS were not informed by scale-up frameworks in design or reporting. The methods and outcomes used in the identified articles were highly variable and limited our ability to draw conclusions about comparative effectiveness although promising approaches emerged. Successes and failures identified in our review largely reflect consensus in the broader literature regarding the need for strategies to better navigate the complexities of system and policy implementation while ensuring CYMHS interventions fit local contexts.
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AIM: To systematically review the effectiveness of caregiver and parent skills training programs, including caregiver-mediated interventions, for caregivers of individuals with neurodevelopmental disorders. METHOD: We conducted a systematic review with a random-effects meta-analysis. We searched 11 electronic databases through July 2021 and used a snowball methodology to locate relevant articles of randomized controlled trials. Effect size estimates were pooled using Hedges' g from data extracted from study reports and through author requests using random-effects meta-analyses for three child outcome categories (child development, adaptive behavior, and problem behavior) and three caregiver outcome categories (parenting skills and knowledge, psychological well-being, and interpersonal family relations). RESULTS: We located 44 910 records, from which 75 randomized controlled trials involving 4746 individuals with neurodevelopmental disorders and their caregivers were included. Random-effects meta-analyses showed improvements in child development (g = 0.30; 99% confidence interval [CI] = 0.07-0.53) and reduction in reported problem behaviors (g = 0.41; 99% CI = 0.24-0.59), but not a statistically significant improvement in adaptive behavior (g = 0.28; 99% CI = -0.42 to 0.98). Caregivers showed improvements in parenting skills and knowledge (g = 0.72; 99% CI = 0.53-0.90), psychological well-being (g = 0.52; 99% CI = 0.34-0.71), and interpersonal family relations (g = 0.76; 99% CI = 0.32-1.20). INTERPRETATION: Caregiver skills training programs benefit both caregivers and children with neurodevelopmental disorders. Skills training programs improve child development and behavior, improve parenting skills, reduce caregiver mental health issues, and improve family functioning. Programs using culturally appropriate training material to improve the development, functioning, and participation of children within families and communities should be considered when caring for children with neurodevelopmental disorders.
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BACKGROUND: Globally, there is a vast mental health treatment gap, whereby the majority of adolescents living in low- and middle-income countries requiring mental health services, do not have access to adequate care. To improve access, the World Health Organization (WHO) developed a range of interventions, designed to be low-cost and delivered by non-specialists. We conducted a two-arm, individually randomised group treatment feasibility trial of a new WHO group intervention for young adolescents with emotional distress ('Early Adolescent Skills for Emotions'; EASE) in Lebanon. METHOD: The aim of this study was to determine the feasibility of the intervention and study procedures. Adolescents aged 10 to 14 years were eligible to take part if they scored above a validated cut-off on the Child Psychosocial Distress Screener. Participants were randomized to EASE or enhanced treatment as usual (ETAU) control using a 1:1 ratio. EASE consisted of seven group sessions with adolescents and three sessions with caregivers. ETAU consisted of a single brief psychoeducation home visit. Child and caregiver outcomes were measured by blind assessors at baseline, endline (8 weeks post-randomisation), and three month follow-up (20 weeks post-randomisation), with the primary outcome measure being child psychological symptoms on the Pediatric Symptom Checklist. Qualitative interviews were conducted with adolescents (n = 13), caregivers (n = 17), facilitators (n = 6), trainers (n = 3), and outreach staff (n = 1) at endline to assess barriers and facilitators related to the feasibility and delivery of EASE and study procedures. RESULTS: Of 154 adolescents screened, 67 (43%) were eligible, completed baseline, and were randomized. Sixty adolescents (90%) completed endline assessments (31 EASE, 29 ETAU), and fifty-nine (88%) completed three-month assessments (29 EASE, 30 ETAU). Qualitatively, participants provided overall positive feedback about the intervention. Several challenges and suggestions for improvement were raised around logistics, intervention content, and acceptability of assessment measures. Implementation data highlighted challenges with intervention uptake and attendance. Outcome measures generally had strong psychometric properties (range: α = 0.77 to α = 87), however did not demonstrate change over time in either group. CONCLUSIONS: The EASE intervention and study procedures are acceptable and feasible for implementation with vulnerable adolescents in Lebanon, however several improvements are necessary prior to full-scale evaluation. TRIAL REGISTRATION: #ISRCTN60799626, retrospectively registered on 04/10/2022.
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Angústia Psicológica , Intervenção Psicossocial , Adolescente , Humanos , Criança , Estudos de Viabilidade , Líbano , EmoçõesRESUMO
ETV6::ABL1 rearranged neoplasms are rare hematological diseases. To date, about 80 cases have been reported, including myeloid and lymphoid leukemias. The ETV6 gene codes for an ETS family transcription factor and several fusion partners have been described. When translocated, ETV6 causes the constitutive activation of the partner genes. Here, we report the case of a 54-year-old woman with a cryptic insertion of the 3' region of ABL1 in the ETV6 gene. The patient was first diagnosed with idiopathic hypereosinophilic syndrome, according to the clinical history, conventional cytogenetics, standard molecular analyses and pathologist description. Next generation sequencing of diagnosis samples unexpectedly detected both ETV6::ABL1 type A and B fusion transcripts, which were then confirmed by FISH. The diagnosis was Myeloid/Lymphoid neoplasm with ETV6::ABL1 fusion, and the patient received imatinib mesylate treatment. In a follow-up after more than one year, the patient still maintained the molecular and complete hematological responses. This case highlights the importance of timely and proper diagnostics and prompt tyrosine kinase inhibitor treatment.
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Síndrome Hipereosinofílica , Transtornos Mieloproliferativos , Neoplasias , Feminino , Humanos , Pessoa de Meia-Idade , Mesilato de Imatinib/uso terapêutico , Inibidores de Proteínas Quinases , Citogenética , Proteínas Proto-Oncogênicas c-ets/genéticaRESUMO
BACKGROUND: Autism presents with similar prevalence and core impairments in diverse populations. We conducted a scoping review of reviews to determine key barriers and innovative strategies which can contribute to attaining universal health coverage (UHC), from early detection to effective interventions for autism in low- and middle-income countries (LAMIC). METHODS: A systematic literature search of review articles was conducted. Reviews relevant to the study research question were included if they incorporated papers from LAMIC and focused on children (Assuntos
Transtorno do Espectro Autista
, Cobertura Universal do Seguro de Saúde
, Transtorno do Espectro Autista/epidemiologia
, Transtorno do Espectro Autista/terapia
, Criança
, Desenvolvimento Infantil
, Pré-Escolar
, Países em Desenvolvimento
, Humanos
, Pobreza
, Literatura de Revisão como Assunto
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BACKGROUND: Pregnancy and parenthood are known to be high-risk times for mental health. However, less is known about the mental health of pregnant adolescents or adolescent parents. Despite the substantial literature on the risks associated with adolescent pregnancy, there is limited evidence on best practices for preventing poor mental health in this vulnerable group. This systematic review therefore aimed to identify whether psychosocial interventions can effectively promote positive mental health and prevent mental health conditions in pregnant and parenting adolescents. METHODS: We used the standardized systematic review methodology based on the process outlined in the World Health Organization's Handbook for Guidelines Development. This review focused on randomized controlled trials of preventive psychosocial interventions to promote the mental health of pregnant and parenting adolescents, as compared to treatment as usual. We searched PubMed/Medline, PsycINFO, ERIC, EMBASE and ASSIA databases, as well as reference lists of relevant articles, grey literature, and consultation with experts in the field. GRADE was used to assess the quality of evidence. RESULTS: We included 17 eligible studies (n = 3245 participants). Interventions had small to moderate, beneficial effects on positive mental health (SMD = 0.35, very low quality evidence), and moderate beneficial effects on school attendance (SMD = 0.64, high quality evidence). There was limited evidence for the effectiveness of psychosocial interventions on mental health disorders including depression and anxiety, substance use, risky sexual and reproductive health behaviors, adherence to antenatal and postnatal care, and parenting skills. There were no available data for outcomes on self-harm and suicide; aggressive, disruptive, and oppositional behaviors; or exposure to intimate partner violence. Only two studies included adolescent fathers. No studies were based in low- or middle-income countries. CONCLUSION: Despite the encouraging findings in terms of effects on positive mental health and school attendance outcomes, there is a critical evidence gap related to the effectiveness of psychosocial interventions for improving mental health, preventing disorders, self-harm, and other risk behaviors among pregnant and parenting adolescents. There is an urgent need to adapt and design new psychosocial interventions that can be pilot-tested and scaled with pregnant adolescents and adolescent parents and their extended networks, particularly in low-income settings.
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Saúde Mental , Poder Familiar/psicologia , Pais/psicologia , Gravidez na Adolescência/psicologia , Intervenção Psicossocial , Adolescente , Feminino , Humanos , Masculino , GravidezRESUMO
Background: Play is essential for the cognitive, social, and emotional development of all children. Disparities potentially exist in access to play for children with disabilities, and the extent of this inequity is unknown. Methods: Data from 212,194 children aged 2-4 years in 38 Low and Middle-Income Countries were collected in the UNICEF supported Multiple Indicator Cluster Survey (2017-2020). Disability was assessed by the Washington Group-Child Functioning Module. Logistic regression models were applied to investigate the relationship between disability and play opportunities, controlling for age, sex, and wealth status. Meta-analysis was used to pool the estimates (overall, and disaggregated by sex), with heterogeneity assessed by Cochran's Q test. Findings: Children with disabilities have approximately 9% fewer play opportunities than those without disabilities (adjusted RR [aRR] = 0.88, 95% CI = 0.82-0.93), and this varied across countries. Mongolia and Democratic Republic of São Tomé and Príncipe had the lowest likelihood of play opportunities for children with disabilities ((aRR = 0.26, 95% CI = 0.09-0.75; aRR = 0.46, 95% CI = 0.23-0.93, respectively). Moreover, children with disabilities are 17% less likely to be provided with opportunities to play with their mothers (aRR = 0.83, 95% CI: 0.73-0.93), which is further reduced for girls with disabilities (aRR = 0.74, 95% CI: 0.60-0.90) compared to their peers without disabilities. The associations varied by impairment type, and children with communication and learning impairments are less likely to have opportunities for play with aRR of 0.69 (95% CI: 0.60-0.79) and 0.78 (95% CI: 0.71-0.86), compared to those without disabilities, respectively. Interpretation: Children with disabilities are being left behind in their access to play and this is likely to have negative impacts on their overall development and well-being. Funding: HK and TS are funded by HK's NIHR Global Research Professorship (NIHR301621). SR is funded by a Rhodes Scholarship. This study was funded by the Programme for Evidence to Inform Disability Action (PENDA) grant from the UK Foreign, Commonwealth and Development Office.
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[This corrects the article DOI: 10.1016/j.eclinm.2023.102361.].
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This study examined the mechanism of effect of the WHO Caregiver Skills Training (CST) through secondary analysis of a pilot RCT conducted in community settings. Participants were 86 caregivers (77% mothers) of children with ASD (78% male, mean age: 44.8 months) randomized to CST (n = 43) or treatment as usual (n = 43). The primary outcomes, measured at baseline (t1), immediately post-intervention (t2), and 3 months post-intervention (t3), were derived from the coding of caregiver-child free play interactions with the Brief Observation of Social-Communication Change (BOSCC) and the Joint Engagement Rating Inventory scale (JERI). At t3 positive treatment main effects had been observed for caregiver skills supportive of the interaction and for flow of the interaction (JERI), albeit only non-significant changes in the expected direction for child outcomes: autism phenotypic behaviors (BOSCC), joint engagement and availability to interact (JERI). This study tested the theory of change of CST, hypothesizing that the intervention would lead to an improvement on all child and dyad outcomes through an increase in the caregiver skills supportive of the interaction. Serial mediation analyses revealed that the effect of the intervention was significantly influenced by change in caregiver skills. Participation in the intervention led to notable increases in caregiver skills at t2 and t3, which subsequently contributed to improvements at t3 in flow of the interaction, autism phenotypic behavior, joint engagement, and availability to interact. We confirmed our a priori hypothesis showing that change in caregiver skills significantly mediated the effect of treatment on the dyad primary outcome, as well as on the other child outcomes that had shown non-significant changes in the expected direction. Implications for intervention design and policy making in the context of public health services are discussed.
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Transtorno do Espectro Autista , Transtorno Autístico , Transtornos Globais do Desenvolvimento Infantil , Feminino , Criança , Humanos , Masculino , Pré-Escolar , Transtorno do Espectro Autista/terapia , Cuidadores , Transtorno Autístico/terapia , Transtornos Globais do Desenvolvimento Infantil/terapia , Organização Mundial da SaúdeRESUMO
Introduction: Adolescence is a critical time for mental health promotion and prevention and establishing healthy behaviours. Implementing universal, school-based psychosocial interventions can improve short- and long-term health trajectories for adolescents. While these interventions may offer important opportunities for fostering skills and relationships, few school-based interventions have been developed for and tested in low- and middle-income countries (LMICs) where adolescent mental health needs may be significant and under-served. This manuscript details the development of a multi-component, universal school-based intervention, Health Action in ScHools for a Thriving Adolescent Generation (HASHTAG), for adolescents aged 12-15 years in Nepal and South Africa. Methods and results: We describe HASHTAG's development over four phases, combining methods and results as each phase was iteratively conducted between 2018 and 2021. Phase 1 included a systematic review and components analysis, building from WHO guidelines for adolescent mental health. Seven components were strongly supported by the evidence: emotional regulation, stress management, mindfulness, problem-solving, interpersonal skills, assertiveness training, and alcohol and drug education. Phase 2 encompassed site selection, theory of change development, and formative research engagements; research teams in each site engaged adolescents and key adult stakeholders to identify priorities for intervention. Stakeholders voiced preferences for external facilitators and key content and delivery for intervention sessions. These findings informed Phase 3, a draft manual of HASHTAG, including a whole-school component, called Thriving Environment in Schools, and a classroom-based, six-session component, Thrive Together. In Phase 4, participants engaged in consultative workshops to review and contextualise content by country, preparing HASHTAG for implementation in a feasibility trial. Minor adaptations were made in Nepal, including using school nurses and adjusting take-home materials; both country's workshops identified practical considerations for implementing activities. Conclusions: HASHTAG was designed around core evidence-based components to increase translatability across LMICs, while enabling country-specific tailoring to enhance feasibility. Future research will test whether this multi-component, whole-school approach can improve adolescent mental health.
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BACKGROUND: The development of effective treatments for use by non-specialists is listed among the top research priorities for improving the lives of people with mental illness worldwide. The purpose of this review is to appraise which interventions for children with intellectual disabilities or lower-functioning autism spectrum disorders delivered by non-specialist care providers in community settings produce benefits when compared to either a no-treatment control group or treatment-as-usual comparator. METHODS AND FINDINGS: We systematically searched electronic databases through 24 June 2013 to locate prospective controlled studies of psychosocial interventions delivered by non-specialist providers to children with intellectual disabilities or lower-functioning autism spectrum disorders. We screened 234 full papers, of which 34 articles describing 29 studies involving 1,305 participants were included. A majority of the studies included children exclusively with a diagnosis of lower-functioning autism spectrum disorders (15 of 29, 52%). Fifteen of twenty-nine studies (52%) were randomized controlled trials and just under half of all effect sizes (29 of 59, 49%) were greater than 0.50, of which 18 (62%) were statistically significant. For behavior analytic interventions, the best outcomes were shown for development and daily skills; cognitive rehabilitation, training, and support interventions were found to be most effective for improving developmental outcomes, and parent training interventions to be most effective for improving developmental, behavioral, and family outcomes. We also conducted additional subgroup analyses using harvest plots. Limitations include the studies' potential for performance bias and that few were conducted in lower- and middle-income countries. CONCLUSIONS: The findings of this review support the delivery of psychosocial interventions by non-specialist providers to children who have intellectual disabilities or lower-functioning autism spectrum disorders. Given the scarcity of specialists in many low-resource settings, including many lower- and middle-income countries, these findings may provide guidance for scale-up efforts for improving outcomes for children with developmental disorders or lower-functioning autism spectrum disorders. PROTOCOL REGISTRATION: PROSPERO CRD42012002641
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Transtornos Globais do Desenvolvimento Infantil/terapia , Deficiência Intelectual/terapia , Adolescente , Criança , HumanosRESUMO
[This corrects the article DOI: 10.1371/journal.pone.0272077.].
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The World Health Organization-Caregiver Skills Training Program, a parent-mediated early intervention facilitated by non-specialist providers piloted in urban India was evaluated using mixed-methods for feasibility and effects on child and caregiver outcomes. Caregivers (n = 22) of children (2-9 years) with social-communication delays participated in a single-group pre-post study. High rates of caregiver attendance, improved caregiver fidelity, and facilitator competency suggested program feasibility. Caregivers voiced acceptability of various intervention-components. The intervention was associated with improved caregiver-reported skills and knowledge (p < 0.00), reduction in stress (p = 0.03), improved child developmental outcomes on communication and social interaction (p < 0.00), and adaptive behaviors (p < 0.00). Challenges about logistics and availability of time were highlighted. Implications of results in resource-poor settings and recommendations for future feasibility trials are discussed.
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Transtorno do Espectro Autista , Cuidadores , Criança , Humanos , Cuidadores/educação , Estudos de Viabilidade , Organização Mundial da Saúde , ÍndiaRESUMO
There are increasing efforts to scale up services globally for families raising children with developmental disabilities (DDs). Existing interventions, often developed in high income, Western settings, need substantial adaptation before they can be implemented in different contexts. The aim of this study was to explore perspectives on the role that context plays in the adaptation and implementation of interventions targeting caregivers of children with DDs across settings. The study question was applied to the Caregiver Skills Training (CST) programme of the World Health Organization specifically, as well as to stakeholder experiences with caregiver interventions more broadly. Two focus group discussions (FGDs; n = 15 participants) and 25 individual semi-structured interviews were conducted. Participants were caregivers of children with DDs and professionals involved in adapting or implementing the CST across five continents and different income settings. Data were analysed thematically. Four main themes were developed: 1) Setting the scene for adaptations; 2) Integrating an intervention into local public services; 3) Understanding the reality of caregivers; 4) Challenges of sustaining an intervention. Informants thought that contextual adaptations were key for the intervention to fit in locally, even more so than cultural factors. The socio-economic context of caregivers, including poverty, was highlighted as heavily affecting service access and engagement with the intervention. Competing health priorities other than DDs, financial constraints, and management of long-term collaborations were identified as barriers. This study validates the notion that attention to contextual factors is an essential part of the adaptation of caregiver interventions for children with DDs, by providing perspectives from different geographical regions. We recommend a stronger policy and research focus on contextual adaptations of interventions and addressing unmet socio-economic needs of caregivers.
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Cuidadores , Deficiências do Desenvolvimento , Cuidadores/educação , Criança , Grupos Focais , Humanos , PobrezaRESUMO
Feasibility, acceptability and effectiveness data of a virtual adaptation of the WHO Caregiver Skills Training (CST; n = 25) were compared with those of a pilot RCT of CST delivered in person (n = 43) against treatment as usual (TAU; n = 43). Virtual CST was delivered with high levels of integrity, but received lower ratings in some caregiver- and facilitator-rated acceptability and feasibility dimensions. Qualitative analysis identified both benefits (flexibility, convenience, clinical usefulness) and challenges, (technological issues, distraction from family members, emotional distance). Virtual and in-person CST improved significantly more on caregiver competence than TAU; there were no other significant effects. Potential for use of virtual CST as a clinical response in contexts where in-person delivery is not possible is discussed.
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Parents of children with ASD (N = 86; mean age 44.8 months; 67 boys) were randomized to either WHO Caregiver Skills Training (CST) delivered in public health settings in Italy or enhanced treatment-as-usual. Primary blinded outcomes were 3-months post-intervention change scores of autism severity and engagement during caregiver-child interaction. CST was highly acceptable to caregivers and feasibly delivered by trained local clinicians. Intention-to-treat analysis showed a large and significant effect on parent skills supporting joint engagement and a smaller significant effect on flow of interaction. Expected changes in child autism severity and joint engagement did not meet statistical significance. Analysis of secondary outcomes showed a significant effect on parenting stress, self-efficacy, and child gestures. Strategies to improve the effectiveness of CST are discussed.
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Transtorno do Espectro Autista , Relações Pais-Filho , Cuidadores , Pré-Escolar , Serviços de Saúde , Humanos , Masculino , Pais/educação , Projetos Piloto , Organização Mundial da SaúdeRESUMO
LAY ABSTRACT: Across the globe, children with neurodevelopmental disorders, including autism, have limited access to care through public services. To improve access to care the World Health Organization developed a novel, open-access programme: the Caregiver Skills Training programme. The Caregiver Skills Training consists of nine group sessions and three individual home visits, focused on training the caregiver on how to use everyday play and home routines as opportunities for learning and development. We implemented Caregiver Skills Training in public child neuropsychiatry services in Italy and examined with questionnaires and focus groups how feasible it was to deliver the programme in public health settings and how acceptable and relevant it was for caregiver users. We found that the Caregiver Skills Training was largely considered acceptable and relevant for families and feasible to deliver. We discuss potential solutions to address the specific implementation challenges that were identified, such as strategies to improve training of interventionists and overcome barriers to caregiver participation.
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Transtorno do Espectro Autista , Cuidadores , Cuidadores/educação , Criança , Família , Estudos de Viabilidade , Humanos , Organização Mundial da SaúdeRESUMO
Background: Local children with developmental disabilities were deprived of learning opportunities due to recent social and health incidents, resulting in elevating challenging behaviors and familial conflicts. This study explored the acceptability and feasibility of the World Health Organization's Caregiver Skills Training Programme (WHO CST) in alternative delivery modes under new normal and post COVID-19 period. Method: CST was delivered via eLearning (EL), videoconferencing (VC), and in-person hybrid (IP) modes to 34 parent-child dyads, being randomly assigned to modes of asynchronous non-interfering EL (n = 9), synchronous with online coaching VC (n = 7), synchronous with in-person coaching IP (n = 9) and Wait-list Control WLC (n = 9). Data from two standardized scales of General Health Questionnaire (GHQ-12) and Strengths and Difficulties Questionnaire (SDQ), and Post-session and Home Visit Feedback Form by Caregivers that included both structured and open-ended questions were collected before and after intervention. Both quantitative and qualitative approaches were used in studying the collected data. Results: High levels of acceptability and feasibility of the training programme were supported by ratings on comprehensiveness and relevance, agreement with their personal values, duration, and usefulness. IP and VC groups yielded more positive changes than EL and WLC groups with 3, 16, 13, and -3% in General Health Questionnaire (GHQ-12), -13, -15, -6 and 0% in Difficulties-total, and 36.5, 35.5, 5.8 and 2.4% in Prosocial Scale at Strengths and Difficulties Questionnaire (SDQ) for EL, VC, IP, and WLC groups respectively from baseline to 12 weeks after intervention. Results from two standardized scales echoed with qualitative observations that the programme helped improve caregivers' well-being, child's communication, and behaviors across intervention groups. Conclusions: Current findings revealed that CST delivered in three alternative modes were acceptable and feasible, and yielded positive impacts toward both caregivers and children. In-person coaching, and skill-practicing sessions were effective in mitigating child's challenging behaviors while personal interaction, either face-to-face or virtual, is a significant factor in uplifting caregivers' well-being, whereas the self-learning model was appreciated by the busy caregivers. In clinical practice, needs and goals of families and the constraints of remote interventions at the settings should be balanced.
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BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.