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

NCT04838912 | Completed

• 1 other identifier: 1-16-02-37-21
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Autism

Keywords

CBT; Anxiety; Autism; Feasibility; Teenagers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P)

  Change from baseline interview results at 14 weeks

• Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P)

  Change from baseline interview results at 3 months

• Spence Children's Anxiety Scale (SCAS)

  Change from baseline results at 14 weeks

• Spence Children's Anxiety Scale (SCAS)

  Change from baseline results at 3 months

• Children's Anxiety Life Inference Scale (CALIS)

  Change from baseline results at 14 weeks

Study Arms (1)

Cool Kids ASA

EXPERIMENTAL

The Cool Kids (Chilled) ASA anxiety program

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

Interventions

Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders. BEHAVIORAL

CBT program for anxiety in teenagers with autism

Cool Kids ASA

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Auhus University Hospital, Psychiatry

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Anxiety Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 9, 2021
• Study Start: June 1, 2021
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: July 6, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)