Testing a CBT Program for Anxiety in Teenagers With Autism: A Feasibility Study

Study Overview
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Brief Summary
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The objective is to investigate the feasibility of a newly developed manualised group Cognitive Behavioural Therapy (CBT) programme for anxiety in 15 teenagers (aged 13-17 years) with Autism Spectrum Disorder (ASD). Our aim is to focus primarily on acceptability and compliance with the program with some investigation of treatment effects on anxiety diagnosis and anxiety symptoms.

Official Title
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Testing a Cognitive Behavioural Therapy Program for Anxiety in Teenagers on the Autism Spectrum: A Feasibility Study

Conditions
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Anxiety, Autism

Intervention / Treatment
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* Behavioral: Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfil the diagnostic criteria for one or more anxiety diagnoses on the Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P) Obtained a diagnosis of ASD according to the International Classification of Diseases, 10th edition (ICD 10) Exclusion Criteria: low intellectual functioning (<70) active psychosis untreated hyperkinetic disorder inability to speak Danish inability to leave the home inability to attend a group setting inability to meet for treatment caused by other psychiatric disorders.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: Fifteen teenagers aged 13-17 years with an active ASD diagnosis and experiencing life interference anxiety symptoms will be divided into 3 groups and treated with the Cool Kids AST anxiety program
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cool Kids ASA<br>The Cool Kids (Chilled) ASA anxiety program | Behavioral: Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.<br>* CBT program for anxiety in teenagers with autism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Experience of Service Questionnaire | A questionnaire measuring teenagers and parents satisfaction with the treatment. On a Likert scale they will be asked to rate positive statements as 'not true' (1), 'partly true' (2), or 'true' (3) and in an open section freely comment on their experience with the treatment. | Interview at 14 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P) | 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 C/P) | 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. With the interview the disorders are rated with a clinical severity rating (CSR) from 0 (no interference) to 8 (extreme interference) with severity ratings of 4 or above signifying the presence of a clinical disorder. | Change from baseline interview results at 3 months | 
| 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. The items are rated on a 4 point scale: 'never','sometimes', 'often', or 'always' to indicate how often each of the items happens. A higher score means worsen of the symptom. Youth version: Min. score 0, max score 135. Parent version: Min. score 0, max score 117 | 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. The items are rated on a 4 point scale: 'never','sometimes', 'often', or 'always' to indicate how often each of the items happens. A higher score means worsen of the symptom. Youth version: Min. score 0, max score 135. Parent version: Min. score 0, max score 117 | 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. The items are rated on a 5 point scale: 'not at all', 'only a little','sometimes', 'quite a lot', or 'a great deal' to indicate how much impact each of the items has on daily life. A higher score means worsen of the impact. Youth version: Min. score 0, max score 9. Parent version: Min. score 0, max score 64 | 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. The items are rated on a 5 point scale: 'not at all', 'only a little','sometimes', 'quite a lot', or 'a great deal' to indicate how much impact each of the items has on daily life. A higher score means worsen of the impact. Youth version: Min. score 0, max score 9. Parent version: Min. score 0, max score 64 | 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. The items are rated on a 5 point scale: 'not at all','sometimes', 'quite often', 'often' or 'all the time' to indicate how often each of the items occurs. A higher score means increase of the event. Min. score 0, max score 160. | 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. The items are rated on a 5 point scale: 'not at all','sometimes', 'quite often', 'often' or 'all the time' to indicate how often each of the items occurs. A higher score means increase of the event. Min. score 0, max score 160. | Change from baseline results at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Anxiety, Autism, Feasibility, Teenagers