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Completed

NCT Number: NCT05738967

Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

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

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Psychiatry Clinic

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Transdiagnostic cognitive behavioral therapy (CBT)

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.

Other names: CBT

Treatment as Usual

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).

Other names: TAU

Primary outcomes

  1. Revised Children's Anxiety and Depression Scale - Parent-Report

    Time frame: 7 days

    Parent-rated child anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.

  2. Clinical Global Impression - Improvement

    Time frame: 7 days

    Clinician-rated child internalizing symptom improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6 = very much improved).

  3. Clinical Global Impression - Severity of Illness

    Time frame: 7 days

    Clinician-rated child internalizing symptom overall severity. A single item is scored 0-6 (0 = no illness; 6 = extremely severe symptoms).

Secondary outcomes

  1. Revised Children's Anxiety and Depression Scale - Self-Report

    Time frame: 7 days

    Child rated anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.

  2. Pediatric Anxiety Rating Scale modified for Autism

    Time frame: 7 days

    Clinician-rated child anxiety severity. The rating scale first includes a checklist of common anxiety symptoms that are rated as present/absent and is followed by a severity rating scale with five Likert scale items. Each severity item is scored on a 0 to 5 scale, (higher scores correspond to greater severity), yielding a total between 0 and 30.

  3. Children's Depression Rating Scale, Revised

    Time frame: 7 days

    Clinician-rated child depression severity. It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (higher scores correspond to greater severity), yielding a total between 17 and 113.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Texas Higher Education Coordinating Board

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2023
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

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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