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

中文翻译：

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技术辅助、家庭志愿者提供的、简短的、多组成部分的父母技能培训干预对巴基斯坦农村发育障碍儿童的有效性：一项集群随机对照试验

在全球范围内，有发育障碍的家庭和儿童的需求与可用服务之间存在巨大的记录差距。我们将世界卫生组织的心理健康差距干预指南 (mhGAP-IG) 发育障碍模块改编成基于平板电脑的 Android 应用程序，以培训发育障碍儿童的护理人员。我们旨在评估这种技术辅助、家庭志愿者提供的父母技能培训干预的有效性，以改善巴基斯坦拉瓦尔品第农村社区发育障碍儿童的功能。在一项单盲、集群随机对照试验中，30 个集群被随机分配（1:1 的比例）到干预（n = 15）或加强照常治疗（ETAU）组（n = 15）。筛选后，540 名 2-12 岁的儿童（每组 18 名参与者），患有发育障碍的患者及其主要照顾者被招募到试验中。主要结果是儿童的功能，通过干预后 6 个月的发育障碍儿童残疾评估表 (DD-CDAS) 测量。次要结果是父母与健康相关的生活质量、照顾者与儿童的共同参与、儿童的社会情感福祉、家庭赋权和污名化经历。意向治疗分析是使用针对协变量和聚类进行调整的混合模型进行的。在干预后 6 个月，干预和 ETAU 之间的 DD-CDAS 没有观察到统计学上显着的平均差异（平均 [SD]，47.65 [26.94] vs. 48.72 [28.37]，调整后的平均差异 (AMD)，- 2.63； 95% 置信区间 - 6.50 至 1.24）。然而，干预组的父母，与 ETAU 报告的健康相关生活质量相比有所改善（平均 [SD] 65.56 [23.25] 与 62.17 [22.63]，AMD 5.28；95% CI 0.44 至 10.11）。结果对于其他次要结果不显着。在 6 个月的相对较短的干预期内，未观察到儿童功能的改善；但是，护理人员的健康相关生活质量有了显着改善。建议进行更长时间随访的进一步试验来评估干预的影响。试验注册 Clinicaltrials.gov，NCT02792894。2016 年 4 月 4 日注册，https://clinicaltrials.gov/ct2/show/NCT02792894 未观察到儿童功能改善；但是，护理人员的健康相关生活质量有了显着改善。建议进行更长时间随访的进一步试验来评估干预的影响。试验注册 Clinicaltrials.gov，NCT02792894。2016 年 4 月 4 日注册，https://clinicaltrials.gov/ct2/show/NCT02792894 未观察到儿童功能改善；但是，护理人员的健康相关生活质量有了显着改善。建议进行更长时间随访的进一步试验，以评估干预的影响。试验注册 Clinicaltrials.gov，NCT02792894。2016 年 4 月 4 日注册，https://clinicaltrials.gov/ct2/show/NCT02792894