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Completed

NCT Number: NCT04838912

Testing a CBT Program for Anxiety in Teenagers With Autism: 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.

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auhus University Hospital, Psychiatry

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

CBT program for anxiety in teenagers with autism

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Testing a Cognitive Behavioural Therapy Program for Anxiety in Teenagers on the Autism Spectrum: A Feasibility Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2021
Registry last updated
Jul 6, 2023

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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