Hamdani Syed Usman, Huma Zill-E-, Suleman Nadia, Akhtar Parveen, Nazir Huma, Masood Aqsa, Tariq Mahjabeen, Koukab Ahmareen, Salomone Erica, Pacione Laura, Brown Felicity, Shire Stephanie, Sikander Siham, Servili Chiara, Wang Duolao, Minhas Fareed Aslam, Rahman Atif
Institute of Psychiatry, Rawalpindi Medical University (RMU) and Benazir Bhutto Hospital, Rawalpindi, Pakistan.
University of Liverpool, Liverpool, UK.
Int J Ment Health Syst. 2021 May 31;15(1):53. doi: 10.1186/s13033-021-00476-w.
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.
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.
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.
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.
在全球范围内，发育障碍儿童及其家庭的需求与现有服务之间存在着有大量文献记载的差距。我们将世界卫生组织的精神卫生差距干预指南（mhGAP-IG）发育障碍模块改编为一款基于平板电脑的安卓应用程序，用于培训发育障碍儿童的照料者。我们旨在评估这种由家庭志愿者提供的、基于技术辅助的父母技能培训干预措施在巴基斯坦拉瓦尔品第农村社区改善发育障碍儿童功能方面的有效性。
在一项单盲、整群随机对照试验中，30个整群被随机分组（1:1比例），分别进入干预组（n = 15）或强化常规治疗组（ETAU，n = 15）。经过筛查，招募了540名年龄在2至12岁、患有发育障碍的儿童及其主要照料者参与试验。主要结局是干预6个月后通过发育障碍儿童残疾评估量表（DD-CDAS）测量的儿童功能。次要结局包括父母的健康相关生活质量、照料者与儿童的共同参与度、儿童的社会情感幸福感、家庭赋权以及污名化经历。采用混合模型进行意向性分析，并对协变量和整群进行了调整。
干预6个月后，干预组和强化常规治疗组在DD-CDAS上未观察到统计学上的显著平均差异（均值[标准差]，47.65[26.94]对48.72[28.37]，调整后平均差异（AMD），-2.63；95%置信区间-6.50至1.24）。然而，与强化常规治疗组相比，干预组的父母报告其健康相关生活质量有所改善（均值[标准差]65.56[23.25]对62.17[22.63]，AMD 5.28；95%置信区间0.44至10.11）。其他次要结局的结果无统计学意义。
在为期6个月的相对较短干预期内，未观察到儿童功能有所改善；但照料者的健康相关生活质量有显著改善。建议进行更长随访期的进一步试验，以评估干预的影响。试验注册Clinicaltrials.gov，NCT02792894。于2016年4月4日注册，https://clinicaltrials.gov/ct2/show/NCT02792894。
