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Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05738967
Enrollment
47
Registered
2023-02-22
Start date
2023-03-15
Completion date
2025-05-31
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Autism, Depression, Emotional Disorder

Keywords

Cognitive behavioral therapy, CBT, exposure therapy, behavioral activation

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.

Interventions

BEHAVIORALTransdiagnostic 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.

BEHAVIORALTreatment 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).

Sponsors

Texas Higher Education Coordinating Board
CollaboratorOTHER_GOV
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Revised Children's Anxiety and Depression Scale - Parent-Report7 daysParent-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.
Clinical Global Impression - Improvement7 daysClinician-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 Illness7 daysClinician-rated child internalizing symptom overall severity. A single item is scored 0-6 (0 = no illness; 6 = extremely severe symptoms).

Secondary

MeasureTime frameDescription
Revised Children's Anxiety and Depression Scale - Self-Report7 daysChild 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.
Pediatric Anxiety Rating Scale modified for Autism7 daysClinician-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.
Children's Depression Rating Scale, Revised7 daysClinician-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026