Randomized Treatment Study
Conditions
Brief summary
Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way that interferes with their wellbeing and every day functioning. In this project the investigators will study the effect of the group program The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific developed for children with ASD. The investigators expect a decrease in the overall anxiety level together with an increase in the ability of handling anxiety.
Detailed description
The primary objective is to investigate the effect of a manualised Cognitive Behavioural Therapy (CBT) programme The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) for anxiety disorder adapted to children with Autism Spectrum Disorder (ASD) in a waitlist controlled design. The investigators will investigate treatment effects on anxiety diagnosis and anxiety symptoms. Further, the investigators will investigate outcomes related to general functioning, co-morbid psychiatric disorders (Obsessive-Compulsive Disorder (OCD), hyperkinetic disorder and depression) and level of ASD symptoms (social and communicative skills).
Interventions
BEHAVIORALCBT
The group based manualised CBT intervention consists of The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD).
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* ASD * Anxiety (not necessary diagnosed)
Exclusion criteria
* IQ under 70 * Not meeting diagnostic criteria for primary anxiety diagnosis on ADIS * Active psychosis * Untreated ADHD * Families not able to follow program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spence Children's Anxiety Scale (SCAS), | 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. |
| Children's Anxiety Life Inference Scale (CALIS) | 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. |
| Children's Automatic Thoughts Scale (CATS). | 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. |
Other
| Measure | Time frame |
|---|---|
| Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS) | Change from baseline results at 14 weeks |
| Adaptive Behaviour Assessment System, Second Edition (ABAS-II) | Change from baseline results at 14 weeks |
| Social Responsiveness Scale (SRS) | Change from baseline results at 14 weeks |
| Strength and Difficulties Questionnaire (SDQ) | Change from baseline results at 14 weeks |
| The WHO-five Well-being Index (WHO-5) | Change from baseline results at 14 weeks |
Countries
Denmark
Outcome results
None listed