Effect of a Family-centered Early Intervention on Psychological Symptoms and Quality of Life in Mothers of Children with Down Syndrome: A Randomized Clinical Trial

Objective Down syndrome (DS) is the most common chromosomal abnormality among liveborn infants. It can negatively affect the quality of life (QOL) and mental health of parents. This study aims to assess the impact of a family-centered early educational intervention on the QOL and psychological symptoms of mothers of children with DS. Materials & Methods This single-blind randomized clinical trial was conducted on 70 mothers of children with DS attending the DS Association in Isfahan, Iran, who had a general health questionnaire-28 item (GHQ-28) score >23. They were selected using a convenience sampling method and randomly assigned to two groups of intervention (n=35) and control (n=35) using the block randomization method. For the intervention group, early educational intervention was provided individually using an educational booklet and at four one-hour sessions for four weeks. Then, they received weekly telephone follow-ups for three months. The control group received only their usual treatments, including occupational therapy, speech therapy, and behavioral therapy. They completed the depression, anxiety, and stress scale (DASS-21) and the World Health Organization QOL scale (WHOQOL-BREF) before and after intervention, and the collected data were analyzed in SPSS software, version 21 using the Mann-Whitney U and Wilcoxon tests. Results In the intervention group, the physical health domain of QOL did not change significantly after intervention (P=0.095), but the domains of psychological health (P=0.002) and environment (P<0.001) showed significant improvement. The score of the social relationships domain significantly reduced (P<0.001). The total WHOQOL-BREF score also significantly increased in the intervention group (P=0.001). In the DASS-21 tool, the scores of depression, anxiety, and stress significantly decreased after intervention (P<0.001). Conclusion The family-centered early educational intervention program can improve the QOL (psychological health and environment domains) and mental health (reducing depression, anxiety, and stress) of mothers of DS children. To enhance the physical health and social relationships domains of QOL in these mothers, longer intervention duration or other methods may be needed.