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Tandem study: Theraplay in children with autism spectrum disorder and their parents.

Tandem studie: Theraplay bij kinderen met een autisme spectrum stoornis en hun ouders.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20704
Enrollment
150
Registered
2019-02-07
Start date
2018-11-19
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autismspectrumdisorder (ASD)

Interventions

Theraplay versus treatment as usual (mainly psycho-education and parental guidance, other therapies such as medication possible)

Sponsors

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
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Is Theraplay an effective treatment for children with ASD and what is the effect of treatment with Theraplay on their parents?

Secondary

MeasureTime frame
1) Does Theraplay improve the parent-child relationship between children with ASD and their parents? 2) Does Theraplay lead to a decrease in psychiatric problems, such as internalizing and externalizing problems and ASD specific traits, in children with ASD? 3) Does Theraplay provide a decrease in both physical and mental parental disstress in parents of a child with ASD? 4) Is head hair cortisol a suitable biomarker for measuring the effectiveness of Theraplay? Amdement on the Tandem study: IMDAD 5) Are immunological and microbiome assessments suitable biomarkers of chronic stress in children with ASD and their parents? 6) Are these immunological and microbiome biomarkers suitable predictors of therapeutic effectiveness? 7) Does Theraplay reduce the biological effects of stress?

Contacts

Public ContactLeanne Dijkstra-de Neijs

Youz part of the Parnassia Group

l.dijkstra@youz.nl06 13286388

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)