Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

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Description Module


Ignite Creation Date: 2025-12-26 @ 10:59 AM
Ignite Modification Date: 2025-12-26 @ 10:59 AM
NCT ID: NCT07205406
Brief Summary: We conducted a non-randomized control trial. One hundred and forty-one participants in eleven special schools were included in an intervention group (N=71) to participate in parenteral training once a week for five weeks, and in a control group (N=70). Quality of care was evaluated using the Parenting Sense of Competence (PSOC), and quality of life was evaluated using the World Health Organization Quality of Life (WHOQOL-BREF) before and one week after the intervention. The study used within-group analysis (Wilcoxon test) and intergroup analysis (Mann-Whitney U test) to evaluate the effects of group-based parenting training. The Point-biserial correlation test was used to evaluate the effect size.
Detailed Description: This study used a quasi-experimental design, which was conducted based on a pretest-posttest control group. One hundred and forty-one mothers who have children with intellectual disabilities attending special schools in East Java, Indonesia, were recruited and divided into intervention (N=71) and control group (N = 70) according to a special school using a convenience sampling method. The inclusion criteria were * having a child aged 7-18 years who has mild and moderate intellectual disabilities * living in the same house as a child with intellectual disabilities, * being able to communicate fluently The exclusion criteria were * having disabilities * having a child with intellectual disabilities who has a chronic disease * having a child with intellectual disabilities and other disabilities Parenting quality was evaluated using the Parenting Sense of Competence (PSOC) developed by Gibaud-Wallston and Wandersman, adapted from Johnston and Marsh. Quality of life was evaluated using the World Health Organization Quality of Life (WHOQOL-BREF) (Cronbach Alpha= 0.66-0.8) developed by the WHO . The control and intervention groups were given a parenting guidebook for children with intellectual disabilities. The intervention group received approximately three hours of parenting training once a week for 5 weeks. The intervention group received parenting training focused on understanding children with intellectual disabilities in the first week, practical parenting skills in the second week, and how to provide emotional support and regulate parental emotions in the third week. Knowledge and skills were reinforced in the fourth and fifth weeks. The intervention group received training in small groups, each consisting of only 10 participants. The training involved experts in mental health counseling, pediatric nurses, special school teachers, and a motivator. The Wilcoxon and Mann-Whitney U tests were used for continuous variables with non-normal distributions, as well as the Chi-squared test for qualitative variables. The Wilcoxon and Mann-Whitney U tests were used for continuous variables with non-normal distributions. A p-value of less than 0.05 was considered statistically significant. The point-biserial correlation test was used to evaluate the effect size.
Study: NCT07205406
Study Brief:
Protocol Section: NCT07205406