Skip to main content
Clinical Trials/NCT05738967
NCT05738967
Completed
N/A

Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

Baylor College of Medicine1 site in 1 country47 target enrollmentMarch 15, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
Baylor College of Medicine
Enrollment
47
Locations
1
Primary Endpoint
Clinical Global Impression - Improvement
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2023
End Date
May 31, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric A Storch

Professor

Baylor College of Medicine

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

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).

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.

Secondary Outcomes

  • 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 Sites (1)

Loading locations...

Similar Trials