跳至主要内容
临床试验/NCT06541782
NCT06541782招募中不适用

Effectiveness of Dyadic Creative Arts Therapies (CAT)-Based Intervention for Improvement of Mother-Child Relationship in Children With Intellectual and Developmental Disabilities: A Mixed Methods RCT

University of Haifa1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Mother-Child Emotional Availability

研究概览

简要总结

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.

详细描述

Background:

Play is crucial to children's development and establishing positive parent-child relationships. Children with IDD face substantial developmental delays that often impact their play behaviors, inclining them toward solitary and repetitive play activities while reducing their social interactions. Interactions between parents and children with IDD tend to be directive and didactic lacking in playfulness and enjoyment. 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. Thus, this novel intervention may benefit children with IDD and their mothers' interactions and relationships, as well as the children's socio-emotional development and the mothers' well-being. The investigators will develop the dyadic play intervention as part of the study while examining feasibility and intervention fidelity.

Objectives: The objectives of this mixed-methods RCT study are: 1) To develop a manualized dyadic CAT-based intervention for children with IDD and their mothers. 2) To measure the effectiveness of the dyadic CAT-based intervention in improving the quality of the mother-child interaction and increasing the mother's and child's playfulness. 3) To explore the mothers' experience within the intervention and its effect on their playfulness, interactions with their children, and the quality of their relationships.

Methods: A mixed-methods approach will be applied, where quantitative and qualitative data are collected and analyzed in parallel.

Participants: The sample will be composed of 60 dyads of children between the ages of 3-7 diagnosed with IDD and their mothers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between the age of 3-7
  • Children with a prior diagnosis of IDD, or studying in special education nursery schools for children with developmental delays
  • The children's mothers

排除标准

  • Children with additional primary diagnosis of autism spectrum disorder or cerebral palsy
  • Children with additional diagnosis of severe physical disability or serious movement limitations
  • Children with additional diagnosis of sensory disorders such as blindness or deafness

结局指标

主要结局

Mother-Child Emotional Availability

时间窗: Baseline, Post-intervention (1week after intervention)

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.

Mother-Child Interpersonal Synchrony

时间窗: Baseline, Post-intervention (1week after intervention)

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.

次要结局

  • Child Playfulness(Baseline, Post-intervention (1 week after intervention))
  • Mother's Parental Playfulness(Baseline, Post-intervention (1 week after intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tal-Chen Rabinowitch

Principal Investigator

University of Haifa

研究点 (1)

Loading locations...

相似试验