Back to resultsTesting a CBT Program for Anxiety in Teenagers With Autism: A Feasibility Study
Primary Purpose
Anxiety, Autism
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring CBT, Anxiety, Autism, Feasibility, Teenagers
Eligibility Criteria
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.
Sites / Locations
- Auhus University Hospital, Psychiatry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cool Kids ASA
Arm Description
The Cool Kids (Chilled) ASA anxiety program
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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
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
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
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04838912
Brief Title
Testing a CBT Program for Anxiety in Teenagers With Autism: A Feasibility Study
Official Title
Testing a Cognitive Behavioural Therapy Program for Anxiety in Teenagers on the Autism Spectrum: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
July 4, 2023 (Actual)
Study Completion Date
July 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Autism
Keywords
CBT, Anxiety, Autism, Feasibility, Teenagers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cool Kids ASA
Arm Type
Experimental
Arm Description
The Cool Kids (Chilled) ASA anxiety program
Intervention Type
Behavioral
Intervention Name(s)
Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.
Intervention Description
CBT program for anxiety in teenagers with autism
Primary Outcome Measure Information:
Title
The Experience of Service Questionnaire
Description
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.
Time Frame
Interview at 14 weeks after start of treatment
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P)
Description
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
Time Frame
Change from baseline interview results at 14 weeks
Title
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P)
Description
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.
Time Frame
Change from baseline interview results at 3 months
Title
Spence Children's Anxiety Scale (SCAS)
Description
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
Time Frame
Change from baseline results at 14 weeks
Title
Spence Children's Anxiety Scale (SCAS)
Description
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
Time Frame
Change from baseline results at 3 months
Title
Children's Anxiety Life Inference Scale (CALIS)
Description
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
Time Frame
Change from baseline results at 14 weeks
Title
Children's Anxiety Life Inference Scale (CALIS)
Description
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
Time Frame
Change from baseline results at 3 months
Title
Children's Automatic Thoughts Scale (CATS)
Description
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.
Time Frame
Change from baseline results at 14 weeks]
Title
Children's Automatic Thoughts Scale (CATS)
Description
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.
Time Frame
Change from baseline results at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Auhus University Hospital, Psychiatry
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will not be shared. Only overall data on the group will be shared due to the Danish Data Protection Act.
Learn more about this trial
Testing a CBT Program for Anxiety in Teenagers With Autism: A Feasibility Study
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