Completed
BIACACBT for Comorbid Anxiety Disorders in Children With Autism, Asperger Syndrome, or PDD-NOS
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What is being tested
Cognitive-behavioral therapy
Behavioral
Who is being recruted
Autistic Disorder+ Asperger Syndrome+ Anxiety Disorders
From 7 to 11 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: January 2005
See protocol details
Summary
Principal SponsorUniversity of California, Los Angeles
Last updated: April 2, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2005Actual date on which the first participant was enrolled.
This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating anxiety symptoms, social problems, and adaptive behavior deficits in children with autism spectrum disorders.
Anxiety disorders are commonly diagnosed in children with autism, Asperger syndrome (AS), and pervasive developmental disorder not otherwise specified (PDD-NOS). Anxiety disorders contribute to children's functional impairment over and above the functional deficits attributable to autism, AS, and PDD-NOS. Thus, investigators have called for the development of anxiety treatments for this population (Attwood, 2003). Cognitive behavioral therapy (CBT) has been found to be efficacious for anxiety disorders in typically developing children. This pilot study will advance the field by providing an estimate of the treatment effects of CBT for anxiety disorders among children with autism, AS, or PDD-NOS. The sample will include 20 children aged 7-11 years with autism, AS, or PDD-NOS and a comorbid anxiety disorder. Children will be randomly assigned to immediate treatment or a 3-month waitlist. The manualized CBT program includes traditional anxiety treatment components including coping skills training (e.g., cognitive restructuring), in vivo exposure, operant procedures, and parent training. Additional treatment components have been added to enhance intervention response in children with AS or PDD-NOS, including emotion education, social skills/friendship skills training, and peer tutoring/mentoring modules. Trained graduate students with expertise in CBT and developmental disabilities will serve as therapists. Treatment fidelity will be checked using a session-by-session adherence checklist. Treatment acceptability and consumer satisfaction will be assessed at posttreatment, providing guidance on the extent to which the manual will need to be revised. Multiple measures of children's anxiety, including a structured diagnostic interview administered by an independent evaluator, will comprise the primary outcomes. Children's social functioning, adaptive behavior, and service use will also be assessed to determine if CBT can affect relevant distal outcomes. By comparing outcomes for children in the immediate treatment group versus those in the waitlist group, we will estimate effect sizes of CBT for this population. Subsequently, power analyses will be conducted in planning for a larger clinical trial. This study could contribute to public health efforts to address the mental health needs of the rising number of children diagnosed with autism-spectrum disorders. If CBT is found to be efficacious, it will be the first evidence-based psychological treatment to be successfully adapted for children with autism, AS, and PDD-NOS.
Principal SponsorUniversity of California, Los Angeles
Last updated: April 2, 2012
Sourced from a government-validated database.Claim as a partner
ProtocolThis section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
20 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.
Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.
Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.
Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.
Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.
How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
EligibilityResearchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 7 to 11 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Autistic Disorder
Asperger Syndrome
Anxiety Disorders
Criteria
4 inclusion criteria required to participate
7 - 11 years of age
Meet research criteria for a diagnosis of Asperger Syndrome or PDD-NOS
Meet DSM-IV criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Phobia, Obsessive-Compulsive Disorder
If taking medication, have maintained a stable dose for 1 month prior to baseline assessment
3 exclusion criteria prevent from participating
Child has an IQ of less than 70
Begin taking new medication(s) or current medication dose changes either (1) less than 1 month prior to baseline assessment, or (2) during the study period
For any reason the child or parents appear unable to participate in the treatment program
Ensure optimum compatibilityAdd your profile to know your probability eligibility score.
Study PlanFind out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental
Group II
No Intervention
Study Objectives
Primary Objectives
Secondary Objectives
Study CentersThese are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
CompletedOne Study Center