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Tandem study: The effectivity of Theraplay on children with autism spectrum disorder and their parents.

Tandem study: The effectivity of Theraplay on children with autism spectrum disorder and their parents. - Tandem study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52655
Enrollment
450
Registered
2018-03-07
Start date
2018-11-19
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

autism spectrum disorder AND parental mental and physical distress autism spectrum disorder AND parental mental and physical distress

Interventions

Theraplay is a directive play intervention based on the attachment theory. It is a semi structured treatment method. Before every Theraplay trajectory a MIM-NL-II trajectory is performed. This is a st
observation specifically developed to set the goals within the Theraplay trajectory. In response to the MIM-NL-II the content of the Theraplay sessions will be composed. The Theraplay goals are discus
whether the Theraplay trajectory will be continued or finished depending on the goals being achieved. An average Theraplay trajectory lasts 26 sessions, approximately 8 months. Treatment as usual (TA

Sponsors

Parnassia
Lead Sponsor

Eligibility

Age
2 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Primary diagnoses of autism spectrum disorder. Children with a developmental delay, mental retardation or co-morbid psychiatric disorders, which are often found in children with autism, can be included. 2. Children aged from 3 to 6 years old. 3. Child and parents understand Dutch and can communicate in Dutch without interpreter.

Exclusion criteria

Exclusion criteria: 1. Start of new psychiatric medication within three months before the start of the study. Medication use for longer periods can be continued. Medication can be stopped during the study.  2. Following another concurrent psychological treatment at the same time elsewhere. 3. Child and/or parent(s) have followed any kind of play therapay or play intervention in the past.

Design outcomes

Primary

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

Secondary

MeasureTime frame
The effectiveness of Theraplay on 1) the parent-child relationship between children with ASD and their parents, 2) psychiatric problems, such as internalizing and/or externalizing behavioural problems and autism specific traits within the child, 3) parental mental and 4) physical distress, 5) the use of hair cortisol as a potential biomarker for treatment effectiveness, 6) a decrease of the immunological and microbiological consequences of chronic stress 7) the use of immunological and microbiome measurements as biomarkers of chronic stress 8) the use of immunological and microbiome measurements as biomarkers of treatment effectiveness.

Countries

Netherlands

Contacts

Public ContactH. Swaab

Universiteit Leiden

hswaab@fsw.leidenuniv.nl071-527 3864

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026