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

Recruiting
Conditions
fysieke en mentale stress bij ouders van een kind met ASS
autism spectrum disorder AND parental mental and physical distress
10012562
Registration Number
NL-OMON52655
Lead Sponsor
Parnassia (Den Haag)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
450
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Is Theraplay an effective treatment method for children with ASD and what is<br /><br>the effect of a treatment with Theraplay on their parents?</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The effectiveness of Theraplay on 1) the parent-child relationship between<br /><br>children with ASD and their parents, 2)<br /><br>psychiatric problems, such as internalizing and/or externalizing behavioural<br /><br>problems and autism specific traits within<br /><br>the child, 3) parental mental and 4) physical distress, 5) the use of hair<br /><br>cortisol as a potential biomarker for treatment<br /><br>effectiveness, 6) a decrease of the immunological and microbiological<br /><br>consequences of chronic stress 7) the use of<br /><br>immunological and microbiome measurements as biomarkers of chronic stress 8)<br /><br>the use of immunological and<br /><br>microbiome measurements as biomarkers of treatment effectiveness.</p><br>
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