Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
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| ClinicalTrials.gov Identifier: NCT05738967 |
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Recruitment Status :
Recruiting
First Posted : February 22, 2023
Last Update Posted : May 10, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety Depression Emotional Disorder Autism | Behavioral: Transdiagnostic cognitive behavioral therapy (CBT) Behavioral: Treatment as usual | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 112 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents |
| Actual Study Start Date : | March 15, 2023 |
| Estimated Primary Completion Date : | May 31, 2025 |
| Estimated Study Completion Date : | May 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Transdiagnostic cognitive behavioral therapy |
Behavioral: Transdiagnostic 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.
Other Name: CBT |
| Active Comparator: Treatment as usual |
Behavioral: Treatment 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).
Other Name: TAU |
- 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.
- 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 - 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.
- 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.
- 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.
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| Ages Eligible for Study: | 12 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05738967
| Contact: Andrew G Guzick, Ph.D. | 713-798-3080 | andrew.guzick@bcm.edu | |
| Contact: Eric A Storch, Ph.D. | 713-798-3080 | eric.storch@bcm.edu |
| United States, Texas | |
| Baylor Psychiatry Clinic | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Eric Storch, PhD eric.storch@bcm.edu | |
| Responsible Party: | Eric A Storch, Professor, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT05738967 |
| Other Study ID Numbers: |
H-52639 |
| First Posted: | February 22, 2023 Key Record Dates |
| Last Update Posted: | May 10, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | We plan on publishing the study description, protocol/procedures, and raw data on an OSF website once primary results are published. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Data will be available once the primary results are published in a peer-reviewed journal |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cognitive behavioral therapy CBT exposure therapy behavioral activation |
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Depression Depressive Disorder Anxiety Disorders |
Behavioral Symptoms Mood Disorders Mental Disorders |