Syed Usman Hamdani1,2,3, Zill-E- Huma4,5, Nadia Suleman5, Parveen Akhtar5, Huma Nazir5, Aqsa Masood5, Mahjabeen Tariq5, Ahmareen Koukab5, Erica Salomone6,7, Laura Pacione6,8, Felicity Brown9,10, Stephanie Shire11, Siham Sikander4, Chiara Servili6, Duolao Wang12, Fareed Aslam Minhas13, Atif Rahman4. 1. Institute of Psychiatry, Rawalpindi Medical University (RMU) and Benazir Bhutto Hospital, Rawalpindi, Pakistan. syedusmanhamdani@gmail.com. 2. University of Liverpool, Liverpool, UK. syedusmanhamdani@gmail.com. 3. Human Development Research Foundation, Islamabad, Pakistan. syedusmanhamdani@gmail.com. 4. University of Liverpool, Liverpool, UK. 5. Human Development Research Foundation, Islamabad, Pakistan. 6. Department of Mental Health and Substance Abuse, World Health Organisation, Geneva, Switzerland. 7. Department of Psychology, University of Milan-Bicocca, Milan, Italy. 8. Department of Psychiatry, Division of Child and Youth Mental Health, University of Toronto, Toronto, ON, Canada. 9. Research and Development Department, War Child Holland, Amsterdam, The Netherlands. 10. Institute of Social Science Research, University of Amsterdam, Amsterdam, The Netherlands. 11. Special Education and Clinical Sciences, College of Education, University of Oregon, Eugene, OR, USA. 12. Liverpool School of Tropical Medicine, Liverpool, UK. 13. Institute of Psychiatry, Rawalpindi Medical University (RMU) and Benazir Bhutto Hospital, Rawalpindi, Pakistan.
Abstract
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.
RCT Entities:
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.
Entities:
Keywords:
Caregivers’ skills training; Developmental disorders; Family Volunteers; Low income settings; Low resource settings; Technology assisted task-shifting; WHO mhGAP-IG
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