Dyadic Creative Arts Therapies-based Intervention for Children With Intellectual and Developmental Disabilities
NCT Number: NCT06541782
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intellectual Disabilities Global Developmental Delay
Interventions: BEHAVIORAL: Dyadic CAT-based Intervention|BEHAVIORAL: Psycho-Educational Parent Counseling
Sponsor: University of Haifa
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-22
Completion Date: 2026-12
Locations: University of Haifa, Haifa, Israel

Summary:
Background: Interactions between parents and children with intellectual and developmental disabilities (IDD) tend to be directive and didactic lacking in playfulness and enjoyment. Recent research has shown that parents of children with IDD who engage in more playful, creative, and enjoyable interactions tend to foster more positive relationships with their children. Early interventions have been shown to enhance parent-child interactions and promote cognitive and socio-emotional development in children with IDD.

Objectives: This mixed-methods randomized controlled trial (RCT) study aims to develop a manualized dyadic Creative-Art-Therapies (CAT)-based intervention for children with IDD and their mothers and assess and explore its effects on the quality of the mother-child interaction and relationship.

Methods: This mixed-methods RCT will investigate and compare two conditions: experimental dyadic CAT-based intervention for children with IDD and their mothers and control psycho-educational counseling intended for mothers only. The sample will consist of sixty dyads of children with IDD between the ages of 3-7 and their mothers, who will be randomly assigned either to experimental or control condition. The experimental group (n=30) will receive 8 weekly individual dyadic CAT-based intervention meetings at their homes and involve both the child and the mother, and the control group (n=30) will receive 8 weekly individual psycho-educational counseling meetings online via Zoom and involve the mother only.

Primary Outcome Measures: Mother-Child Emotional Availability, Change in quality of Mother-Child Emotional Availability from baseline to post-intervention. Emotional availability will be assessed from social play without toys task, using Emotional Availability scales which score six sub-scales concerned with emotional regulation in the parent-child dyad: Parent sensitivity (ranging from 1 to 9), parent structuring (ranging from 1 to 5), parent non-intrusiveness (ranging from 1 to 5), parent non-hostility (ranging from 1 to 5), child responsiveness (ranging from 1 to 7), and child involving of parent (ranging from 1 to 7). All scores are averaged into a single emotional availability score for each parent-child dyad, with a higher score signifying an optimal outcome of higher emotional availability., Baseline, Post-intervention (1week after intervention)|Mother-Child Interpersonal Synchrony, Change in Mother-Child Interpersonal Synchrony from baseline to post-intervention. Interpersonal synchrony will be measured during mutual movement task, using OpenPose, a multi-person 2D pose estimator, to extract skeletal information from the videos. The positions of the mother and child during the mutual movement task will be examined for coherence and variance using cross-wavelet analysis method, forming an index between 0 and 1 of the degree of interpersonal synchrony between mother and child, with a higher score signifying an optimal outcome of higher interpersonal synchrony., Baseline, Post-intervention (1week after intervention)
Secondary Outcome Measures: Mother's Parental Playfulness, Change in Mother's Parental Playfulness from baseline to post-intervention. Parental playfulness will be assessed from free play and symbolic play tasks using Parental Playfulness scale which score three sub-scales concerned with parental creativity, imagination, and humor while playing with their children: parent's playful behavior, following the child's lead, and peer-like behavior. Each subscale ranges from 1 to 7 and all scores are averaged into a single parental playfulness score, with a higher score signifying an optimal outcome of higher parental playfulness., Baseline, Post-intervention (1 week after intervention)|Child Playfulness, Change in Child Playfulness from baseline to post-intervention. Child playfulness will be assessed from free play and symbolic play tasks using Test of Playfulness which scores 30 items concerned with the extent, intensity, and skill of the child at free play. Each item ranges from 1 to 3 and all scores are computed into a single child playfulness score, with a higher score signifying an optimal outcome of higher child playfulness., Baseline, Post-intervention (1 week after intervention)