Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541782
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Dyadic Creative Arts Therapies-based Intervention for Children With Intellectual and Developmental Disabilities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n30 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 n30 will receive 8 weekly individual psycho-educational counseling meetings online via Zoom and involve the mother only
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 n30 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 n30 will receive 8 weekly individual psycho-educational counseling meetings online via Zoom and involve the mother only
Detailed Description:
Background
Play is crucial to childrens 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 childrens 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 mothers and childs 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
Study Design and Procedures This is a two-arm RCT that will allocate the participating dyads to one of two conditions experimental arm of dyadic CAT-based intervention or control arm of psycho-educational parent counseling All mother-child dyads will participate in a baseline assessment meeting one week before the first intervention meeting and a final assessment meeting one week after the last intervention meeting each meeting lasting approximately 45 minutes The assessment meetings will measure the quality of the interactions between children with IDD and their mothers and will be video-recorded
The experimental arm of dyadic CAT-based dyadic intervention will include eight individual weekly sessions of a mother and a child with a music or drama therapist in their home environment each session lasting approximately 45 minutes The intervention will aim to facilitate mutual free-play interactions promote enjoyment and fun and enhance the parents and childrens playfulness The dyadic play intervention will be based on the Creative Arts Therapies as they offer a unique approach to cultivating playfulness creativity and self-expression while employing non-verbal and multi-sensorial techniques especially suited to the cognitive and verbal skills of children with IDD As a part of this study a novel intervention treatment guide will be developed and specifically tailored for the studied population
The control arm of psycho-educational parent counseling will include eight individual weekly sessions of a mother and a parent counselor each session lasting approximately 45 minutes The psycho-educational parent counseling will be performed online via Zoom
Behavioral tasks and semi-structured interviews will be conducted Quantitative data will include observational measures of emotional availability EA parent-child interpersonal synchrony IPS parents playfulness via Parent Playfulness scales and childs playfulness via Test of Playfulness Each measure will be collected for each dyad during the assessment meetings at two points of time before and after the intervention period
Qualitative data will include interviews with 35 of the mothers who will participate in the dyadic CAT-based intervention and will be collected following the final assessment meeting and two months after the intervention ends
Play is crucial to childrens 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 childrens 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 mothers and childs 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
Study Design and Procedures This is a two-arm RCT that will allocate the participating dyads to one of two conditions experimental arm of dyadic CAT-based intervention or control arm of psycho-educational parent counseling All mother-child dyads will participate in a baseline assessment meeting one week before the first intervention meeting and a final assessment meeting one week after the last intervention meeting each meeting lasting approximately 45 minutes The assessment meetings will measure the quality of the interactions between children with IDD and their mothers and will be video-recorded
The experimental arm of dyadic CAT-based dyadic intervention will include eight individual weekly sessions of a mother and a child with a music or drama therapist in their home environment each session lasting approximately 45 minutes The intervention will aim to facilitate mutual free-play interactions promote enjoyment and fun and enhance the parents and childrens playfulness The dyadic play intervention will be based on the Creative Arts Therapies as they offer a unique approach to cultivating playfulness creativity and self-expression while employing non-verbal and multi-sensorial techniques especially suited to the cognitive and verbal skills of children with IDD As a part of this study a novel intervention treatment guide will be developed and specifically tailored for the studied population
The control arm of psycho-educational parent counseling will include eight individual weekly sessions of a mother and a parent counselor each session lasting approximately 45 minutes The psycho-educational parent counseling will be performed online via Zoom
Behavioral tasks and semi-structured interviews will be conducted Quantitative data will include observational measures of emotional availability EA parent-child interpersonal synchrony IPS parents playfulness via Parent Playfulness scales and childs playfulness via Test of Playfulness Each measure will be collected for each dyad during the assessment meetings at two points of time before and after the intervention period
Qualitative data will include interviews with 35 of the mothers who will participate in the dyadic CAT-based intervention and will be collected following the final assessment meeting and two months after the intervention ends
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None