Tandem study: Theraplay in children with autism spectrum disorder and their parents.
Recruiting
- Conditions
- Autismspectrumdisorder (ASD)
- Registration Number
- NL-OMON20704
- Lead Sponsor
- 1) Stichting Korczak Foundation for Autism and Related Disorders, 2) Stichting tot Steun VCVGZ, 3)SARR expertise centrum autisme, Youz kinder- en jeugdpsychiatrie, Parnassia Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1. Primary diagnosis of ASD (children with developmental delay, intellectual disability or other co-morbid psychiatric problems are included)
2. Age of the child is between 3 and 6 years.
3. Child and parents can understand and speak Dutch without the need for an interpreter.
Exclusion Criteria
1. Starting new psychopharmaceuticals within 3 months prior to participation in the study. Psychopharmaceuticals that have been used for a longer time can be continued.
2. Following another psychological treatment by the child elsewhere during participation in the study.
3. Having followed any type of play therapy or play based intervention by child and / or parents, prior to participating within this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Is Theraplay an effective treatment for children with ASD and what is the effect of treatment with Theraplay on their parents?
- Secondary Outcome Measures
Name Time Method 1) Does Theraplay improve the parent-child relationship between children with ASD and their parents?<br>2) Does Theraplay lead to a decrease in psychiatric problems, such as internalizing and externalizing problems and ASD specific traits, in children with ASD?<br>3) Does Theraplay provide a decrease in both physical and mental parental disstress in parents of a child with ASD?<br>4) Is head hair cortisol a suitable biomarker for measuring the effectiveness of Theraplay?<br><br>Amdement on the Tandem study: IMDAD<br>5) Are immunological and microbiome assessments suitable biomarkers of chronic stress in children with ASD and their parents?<br>6) Are these immunological and microbiome biomarkers suitable predictors of therapeutic effectiveness?<br>7) Does Theraplay reduce the biological effects of stress?