Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

NCT05738967 | Completed

• 1 other identifier: H-52639
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety; Depression; Emotional Disorder; Autism

Keywords

Cognitive behavioral therapy; CBT; exposure therapy; behavioral activation

Outcome Measures

Primary Outcomes (3)

• Revised Children's Anxiety and Depression Scale - Parent-Report

  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.

  7 days

• Clinical Global Impression - Improvement

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

  7 days

• Clinical Global Impression - Severity of Illness

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

  7 days

Secondary Outcomes (3)

• Revised Children's Anxiety and Depression Scale - Self-Report

  7 days

• Pediatric Anxiety Rating Scale modified for Autism

  7 days

• Children's Depression Rating Scale, Revised

  7 days

Study Arms (2)

Transdiagnostic cognitive behavioral therapy

EXPERIMENTAL

Behavioral: Transdiagnostic cognitive behavioral therapy (CBT)

Treatment as usual

ACTIVE COMPARATOR

Behavioral: Treatment as usual

Interventions

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.

Also known as: CBT

Transdiagnostic cognitive behavioral therapy

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).

Also known as: TAU

Treatment as usual

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Texas Higher Education Coordinating Board: collaborator

Study Sites (1)

Baylor Psychiatry Clinic

Houston, Texas, 77030, United States

Location

Related Publications (6)

• Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.

  PMID: 28423145 BACKGROUND

• van Steensel FJ, Bogels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17. doi: 10.1007/s10567-011-0097-0.

  PMID: 21735077 BACKGROUND

• Hudson CC, Hall L, Harkness KL. Prevalence of Depressive Disorders in Individuals with Autism Spectrum Disorder: a Meta-Analysis. J Abnorm Child Psychol. 2019 Jan;47(1):165-175. doi: 10.1007/s10802-018-0402-1.

  PMID: 29497980 BACKGROUND

• Chu BC, Crocco ST, Esseling P, Areizaga MJ, Lindner AM, Skriner LC. Transdiagnostic group behavioral activation and exposure therapy for youth anxiety and depression: Initial randomized controlled trial. Behav Res Ther. 2016 Jan;76:65-75. doi: 10.1016/j.brat.2015.11.005. Epub 2015 Nov 19.

  PMID: 26655958 BACKGROUND

• Uljarevic M, Hedley D, Rose-Foley K, Magiati I, Cai RY, Dissanayake C, Richdale A, Trollor J. Anxiety and Depression from Adolescence to Old Age in Autism Spectrum Disorder. J Autism Dev Disord. 2020 Sep;50(9):3155-3165. doi: 10.1007/s10803-019-04084-z.

  PMID: 31190198 BACKGROUND

• Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.

  PMID: 31755906 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Autistic Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 22, 2023
• Study Start: March 15, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available once the primary results are published in a peer-reviewed journal

Locations

US (1)