Intellectual Disabilities Global Developmental DelayNCT06541782
Dyadic Creative Arts Therapies-based Intervention for Children With Intellectual and Developmental Disabilities
A study testing Dyadic CAT-based Intervention and Psycho-Educational Parent Counseling in people with Intellectual Disabilities Global Developmental Delay, run by University of Haifa at 1 site in Israel.
Trial summary
Background: Interactions between parents and children with intellectual and developmental disabilities (IDD) tend to be directive and didactic lacking in playfulness and enjoyment. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Intellectual Disabilities Global Developmental Delay
- What is being tested?
- Dyadic CAT-based Intervention and Psycho-Educational Parent Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Feb 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
University of Haifa
Haifa
Rita Abramov, MA, 972-50-2596231, rita.abramov@gmail.com
Amitai Stern, MA, 972-58-6286235, amitaistern1@gmail.com
About this study
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
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.
Read the detailed description
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.
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 children's 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), parent's playfulness (via Parent Playfulness scales), and child's 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.
- Being tested
- Dyadic CAT-based Intervention, Psycho-Educational Parent Counseling
- Keywords
- Music and Play Intervention, Dyadic Intervention, Children with Intellectual and Developmental Disabilities, Playfulness, Parental Playfulness, Mother-Child Relationship
- Medical subject headings
- Learning Disabilities, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic CAT-based InterventionBehavioural
The experimental dyadic CAT-based intervention will promote mutual sensorimotor play, pretend play, songs, and games among the mother-child dyads while encouraging flexibility, creativity, and enjoyment. This intervention will involve eight weekly 45-minute sessions in the families' homes and will be conducted by trained creative art therapists. The dyadic CAT-based intervention will follow a manualized protocol presenting the goals, principles, and proposed activities for the intervention sessions. It will provide instructions for maintaining intervention fidelity, while allowing flexibility to tailor the meetings to each dyad's strengths and needs. The dyadic CAT-based intervention meetings will be recorded using video camera.
Psycho-Educational Parent CounselingBehavioural
This intervention will involve only mothers and will be conducted by trained parent counselors with experience in working with IDD. This intervention will involve eight weekly 45-minute sessions performed online via Zoom. The psycho-educational parent counseling will follow a protocol presenting the goals, principles, and central issues in parenting a child with IDD to improve the parent-child relationship and address concerns and difficulties related to the child's diagnosis, development, and behavior. It will provide general instructions for maintaining study validity and replication, while allowing flexibility to tailor the intervention to each family's needs.
| Study group | Role | What they receive |
|---|---|---|
| Dyadic CAT-based Intervention | Experimental | This arm (n=30) will include dyadic CAT-based intervention only. Receives: Behavioral: Dyadic CAT-based Intervention |
| Psycho-Educational Parent Counseling | Active comparator | This arm (n=30) will include psycho-educational parent counseling only. Receives: Behavioral: Psycho-Educational Parent Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Post-intervention (1week after intervention)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, Post-intervention (1 week after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start22 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual Disabilities Global Developmental DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participating dyad will be randomized into one of two groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tal-Chen Rabinowitch, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541782
- Sponsor's protocol ID
- 3107
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abramov R, Stern A, Feniger-Schaal R, Elefant C, Goldner L, Rabinowitch TC. 'Just Play' (JP) - creative arts therapies-based dyadic intervention for children with intellectual disability and their mothers: Study protocol for a mixed-methods randomized controlled trial. PLoS One. 2026 May 21;21(5):e0349576. doi: 10.1371/journal.pone.0349576. eCollection 2026.
PubMed 42166477
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06541782
- Acronym / sponsor ID
- 3107
- Keywords
- Music and Play Intervention, Dyadic Intervention, Children with Intellectual and Developmental Disabilities, Playfulness, Parental Playfulness, Mother-Child Relationship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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 children's 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), parent's playfulness (via Parent Playfulness scales), and child's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participating dyad will be randomized into one of two groups.
| Arm | Type | Receives |
|---|---|---|
| Dyadic CAT-based Intervention | Experimental | Behavioral: Dyadic CAT-based InterventionThis arm (n=30) will include dyadic CAT-based intervention only. |
| Psycho-Educational Parent Counseling | Active comparator | Behavioral: Psycho-Educational Parent CounselingThis arm (n=30) will include psycho-educational parent counseling only. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic CAT-based InterventionThe experimental dyadic CAT-based intervention will promote mutual sensorimotor play, pretend play, songs, and games among the mother-child dyads while encouraging flexibility, creativity, and enjoyment. This intervention will involve eight weekly 45-minute sessions in the families' homes and will be conducted by trained creative art therapists. The dyadic CAT-based intervention will follow a manualized protocol presenting the goals, principles, and proposed activities for the intervention sessions. It will provide instructions for maintaining intervention fidelity, while allowing flexibility to tailor the meetings to each dyad's strengths and needs. The dyadic CAT-based intervention meetings will be recorded using video camera. | Behavioural | Dyadic CAT-based Intervention |
| Psycho-Educational Parent CounselingThis intervention will involve only mothers and will be conducted by trained parent counselors with experience in working with IDD. This intervention will involve eight weekly 45-minute sessions performed online via Zoom. The psycho-educational parent counseling will follow a protocol presenting the goals, principles, and central issues in parenting a child with IDD to improve the parent-child relationship and address concerns and difficulties related to the child's diagnosis, development, and behavior. It will provide general instructions for maintaining study validity and replication, while allowing flexibility to tailor the intervention to each family's needs. | Behavioural | Psycho-Educational Parent Counseling |
Primary outcome
Mother-Child Emotional Availability
Time frame: 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
Time frame: 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.
2 secondary outcomes
Mother's Parental Playfulness
Time frame: Baseline, Post-intervention (1 week after intervention)
Child Playfulness
Time frame: Baseline, Post-intervention (1 week after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 42166477Abramov R, Stern A, Feniger-Schaal R, Elefant C, Goldner L, Rabinowitch TC. 'Just Play' (JP) - creative arts therapies-based dyadic intervention for children with intellectual disability and their mothers: Study protocol for a mixed-methods randomized controlled trial. PLoS One. 2026 May 21;21(5):e0349576. doi: 10.1371/journal.pone.0349576. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic CAT-based Intervention and Psycho-Educational Parent Counseling in people with Intellectual Disabilities Global Developmental Delay, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tal-Chen Rabinowitch, PhD (972-51-2722144, talchenr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-Child Emotional Availability (time frame: Baseline, Post-intervention (1week after intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06541782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.