Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2025-05-31

Brief Summary

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This study tests the effectiveness of a transdiagnostic cognitive behavioral therapy for autistic youth with anxiety and/or depression.

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Detailed Description

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About 1 in 54 adolescents are estimated to be on the autism spectrum, with over half suffering from anxiety or depressive disorders. These disorders contribute to suicidality, family stress, social impairments, and difficulties transitioning to adulthood among autistic youth. Given the frequency of anxiety and depressive disorders among autistic adolescents and the increased risk of impairment, developing effective treatments for anxiety and depression tailored to this population is a top priority.

Transdiagnostic cognitive behavioral therapy (CBT) for other populations, including typically developing adolescents, may confer broader benefits than disorder-specific CBT and facilitate broader dissemination and implementation. However, there has been little research conducted on transdiagnostic treatments among autistic adolescents. Thus, this study proposes to address this gap by testing transdiagnostic CBT for autistic adolescents with anxiety and depression.

The study involves two phases: 1) a pilot intervention; and 2) a randomized controlled trial.

The pilot intervention will involve 12 adolescent-caregiver dyads to further refine the treatment model and its assessment measures. The randomized trial will involve 100 adolescent-caregiver dyads to further evaluate the clinical efficacy of the treatment.

Conditions

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Anxiety Depression Emotional Disorder Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transdiagnostic cognitive behavioral therapy

Group Type EXPERIMENTAL

Transdiagnostic cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

Adolescent-caregiver dyads will will participate in CBT focused on exposure therapy and behavioral activation. It will also include flexible incorporation of emotion-focused coping and adaptations for autism.

Treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Adolescent-caregiver dyads will participate in coordinated referrals to the community. They may receive psychotherapy and/or initiate or change current psychiatric medication (if applicable).

Interventions

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Transdiagnostic cognitive behavioral therapy (CBT)

Adolescent-caregiver dyads will will participate in CBT focused on exposure therapy and behavioral activation. It will also include flexible incorporation of emotion-focused coping and adaptations for autism.

Intervention Type BEHAVIORAL

Treatment as usual

Adolescent-caregiver dyads will participate in coordinated referrals to the community. They may receive psychotherapy and/or initiate or change current psychiatric medication (if applicable).

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT TAU

Eligibility Criteria

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Inclusion Criteria

* Child is between the ages of 12-17 at consent/assent.
* The child meets criteria for autism spectrum disorder using evidence-based assessment approaches (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition).
* The child meets criteria for clinically significant anxiety and/or depression symptoms based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (\>11) and/or the Children's Depression Rating Scale-Revised (\>39).
* Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview
* One parent/guardian is able and willing to participate.
* The parent/guardian is 18 years or older.
* Both parent and child can read and/or understand English.
* Both parent and child reside in Texas.

Exclusion Criteria

* The child has a diagnosis of psychotic disorder and/or conduct disorder.
* The child has severe suicidal/homicidal ideation and/or self-injury requiring immediate intervention and/or a higher level of care.
* The child has limited verbal communication abilities.
* The child is receiving concurrent psychotherapy for anxiety/depression.
* The child has initiated psychotropic medications within 12 weeks of assessments (or 4 weeks for stimulants/benzodiazepines) or during therapy, and/or has changed dosage of psychotropic medication within 6 weeks of assessment (or 2 weeks for stimulants/benzodiazepines) or during therapy.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No