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Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

Baylor College of Medicine logo

Baylor College of Medicine

Status

Completed

Conditions

Emotional Disorder
Depression
Anxiety
Autism

Treatments

Behavioral: Treatment as usual
Behavioral: Transdiagnostic cognitive behavioral therapy (CBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05738967
H-52639

Details and patient eligibility

About

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

Full 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.

Enrollment

47 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

47 participants in 2 patient groups

Transdiagnostic cognitive behavioral therapy
Experimental group
Treatment:
Behavioral: Transdiagnostic cognitive behavioral therapy (CBT)
Treatment as usual
Active Comparator group
Treatment:
Behavioral: Treatment as usual

Trial contacts and locations

1

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Central trial contact

Eric A Storch, Ph.D.; Andrew G Guzick, Ph.D.

Data sourced from clinicaltrials.gov

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