AnxietyNCT04838912
Testing a CBT Program for Anxiety in Teenagers With Autism: A Feasibility Study
A study testing Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders. in people with Anxiety and Autism, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 18 years
- What is being tested?
- Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2021to 4 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Cognitive Behavioural Therapy Program for Anxiety in Teenagers on the Autism Spectrum: A Feasibility Study
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.
- Being tested
- Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.
- Keywords
- CBT, Anxiety, Autism, Feasibility, Teenagers
- Medical subject headings
- Anxiety Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.Behavioural
CBT program for anxiety in teenagers with autism
| Study group | Role | What they receive |
|---|---|---|
| Cool Kids ASA | Experimental | The Cool Kids (Chilled) ASA anxiety program Receives: Behavioral: Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from baseline results at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Jun 2021
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838912
- Sponsor's protocol ID
- 1-16-02-37-21
- Status last verified
- Nov 2022
- First submitted
- 25 Mar 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared. Only overall data on the group will be shared due to the Danish Data Protection Act.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Cognitive Behavioural Therapy Program for Anxiety in Teenagers on the Autism Spectrum: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04838912
- Acronym / sponsor ID
- 1-16-02-37-21
- Keywords
- CBT, Anxiety, Autism, Feasibility, Teenagers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Cool Kids ASA | Experimental | Behavioral: Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.The Cool Kids (Chilled) ASA anxiety program |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- low intellectual functioning (<70)
- active psychosis
- untreated hyperkinetic disorder
- inability to speak Danish
- inability to leave the home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.CBT program for anxiety in teenagers with autism | Behavioural | Cool Kids ASA |
Primary outcome
The Experience of Service Questionnaire
Time frame: 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.
8 secondary outcomes
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P)
Time frame: Change from baseline interview results at 14 weeks
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS C/P)
Time frame: Change from baseline interview results at 3 months
Spence Children's Anxiety Scale (SCAS)
Time frame: Change from baseline results at 14 weeks
Spence Children's Anxiety Scale (SCAS)
Time frame: Change from baseline results at 3 months
Children's Anxiety Life Inference Scale (CALIS)
Time frame: Change from baseline results at 14 weeks
Children's Anxiety Life Inference Scale (CALIS)
Time frame: Change from baseline results at 3 months
Children's Automatic Thoughts Scale (CATS)
Time frame: Change from baseline results at 14 weeks]
Children's Automatic Thoughts Scale (CATS)
Time frame: Change from baseline results at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No. Individual data will not be shared. Only overall data on the group will be shared due to the Danish Data Protection Act.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders. in people with Anxiety and Autism, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Experience of Service Questionnaire (time frame: Interview at 14 weeks after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.