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

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04838912
Collaborator
(none)
15
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cool Kids (Chilled) Anxiety program adapted to children and youths with anxiety disorders (ASA)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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 programFifteen 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)
Primary Purpose:
Treatment
Official Title:
Testing a Cognitive Behavioural Therapy Program for Anxiety in Teenagers on the Autism Spectrum: A Feasibility Study
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cool Kids ASA

The Cool Kids ASA anxiety program

Behavioral: Cool Kids (Chilled) Anxiety program adapted to children and youths with anxiety disorders (ASA)
CBT program for anxiety in teenagers with autism

Outcome Measures

Primary Outcome Measures

  1. The Experience of Service Questionnaire [Interview at 14 weeks after start of treatment]

    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.

Secondary Outcome Measures

  1. Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P) [Change from baseline interview results at 14 weeks]

    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

  2. Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P) [Change from baseline interview results at 3 months]

    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.

  3. Spence Children's Anxiety Scale (SCAS) [Change from baseline results at 14 weeks]

    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

  4. Spence Children's Anxiety Scale (SCAS) [Change from baseline results at 3 months]

    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

  5. Children's Anxiety Life Inference Scale (CALIS) [Change from baseline results at 14 weeks]

    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

  6. Children's Anxiety Life Inference Scale (CALIS) [Change from baseline results at 3 months]

    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

  7. Children's Automatic Thoughts Scale (CATS) [Change from baseline results at 14 weeks]]

    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.

  8. Children's Automatic Thoughts Scale (CATS) [Change from baseline results at 3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Auhus University Hospital, Psychiatry Aarhus N Denmark 8200

Sponsors and Collaborators

  • University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT04838912
Other Study ID Numbers:
  • 1-16-02-37-21
First Posted:
Apr 9, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021