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

Not Applicable

Completed

• Conditions: Anxiety; Autism
• Interventions: Behavioral: Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.

• Registration Number: NCT04838912
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-09
• Study Start: 2021-06-01
• Status Verified: 2022-11
• Primary Completion: 2023-07-04
• Study Completion: 2023-07-04
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cool Kids ASA	Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.	The Cool Kids (Chilled) ASA anxiety program

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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
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.

Trial Locations

Locations (1)

Auhus University Hospital, Psychiatry; 🇩🇰 Aarhus N, Denmark