CBT for Anxiety Disorder in Children With Co-morbid ASD

Study Overview
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Brief Summary
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Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way that interferes with their wellbeing and every day functioning. In this project the investigators will study the effect of the group program The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific developed for children with ASD. The investigators expect a decrease in the overall anxiety level together with an increase in the ability of handling anxiety.

Detailed Description
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The primary objective is to investigate the effect of a manualised Cognitive Behavioural Therapy (CBT) programme The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) for anxiety disorder adapted to children with Autism Spectrum Disorder (ASD) in a waitlist controlled design. The investigators will investigate treatment effects on anxiety diagnosis and anxiety symptoms. Further, the investigators will investigate outcomes related to general functioning, co-morbid psychiatric disorders (Obsessive-Compulsive Disorder (OCD), hyperkinetic disorder and depression) and level of ASD symptoms (social and communicative skills).

Official Title
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Cognitive Behavioural Therapy for Anxiety Disorder in Children With Co-morbid Autism Spectrum Disorder

Conditions
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Randomized Treatment Study

Intervention / Treatment
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* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASD Anxiety (not necessary diagnosed) Exclusion Criteria: IQ under 70 Not meeting diagnostic criteria for primary anxiety diagnosis on ADIS Active psychosis Untreated ADHD Families not able to follow program

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT<br> | Behavioral: CBT<br>* The group based manualised CBT intervention consists of The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD).<br>* Other names: Cool Kids ASD;|
| No Intervention: WL<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). | ADIS/CP is a structured interview involving both child and parents designed to assess for current episodes of anxiety disorders, and to permit differential diagnosis among the anxiety disorders according to DSM-IV criteria. | Change from baseline interview results at 14 weeks | 
| Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). | ADIS/CP is a structured interview involving both child and parents designed to assess for current episodes of anxiety disorders, and to permit differential diagnosis among the anxiety disorders according to DSM-IV criteria. | Change from baseline interview results at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spence Children's Anxiety Scale (SCAS), | SCAS is a questionnaire for children and parents assessing the severity of anxiety symptoms broadly in line with the dimensions of anxiety disorder proposed by the DSM-IV. The scale assesses six domains of anxiety including generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive-compulsive disorder and physical injury fears. | Change from baseline results at 14 weeks | 
| Spence Children's Anxiety Scale (SCAS), | SCAS is a questionnaire for children and parents assessing the severity of anxiety symptoms broadly in line with the dimensions of anxiety disorder proposed by the DSM-IV. The scale assesses six domains of anxiety including generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive-compulsive disorder and physical injury fears. | Change from baseline results at 3 months | 
| Children's Anxiety Life Inference Scale (CALIS) | CALIS is designed to assess life interference attributed to fears and worries from child and parent perspectives. The measure targets interference on the child's life and on the parent's/family's life. | Change from baseline results at 14 weeks | 
| Children's Anxiety Life Inference Scale (CALIS) | CALIS is designed to assess life interference attributed to fears and worries from child and parent perspectives. The measure targets interference on the child's life and on the parent's/family's life. | Change from baseline results at 3 months | 
| Children's Automatic Thoughts Scale (CATS). | CATS is a developmentally sensitive, general measure of negative self-statements across both internalizing and externalizing problems. Four separate subscales of cognitive content are assessed including physical threat, social threat, personal failure, and hostility. | Change from baseline results at 14 weeks | 
| Children's Automatic Thoughts Scale (CATS). | CATS is a developmentally sensitive, general measure of negative self-statements across both internalizing and externalizing problems. Four separate subscales of cognitive content are assessed including physical threat, social threat, personal failure, and hostility. | Change from baseline results at 3 months |