Clinical trial NCT05738967: Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
Official title: Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Emotional Disorder
Autism
Keywords: Cognitive behavioral therapy
CBT
exposure therapy
behavioral activation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Texas Higher Education Coordinating Board
First posted: 2023-02-22
Enrollment: 112
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Revised Children's Anxiety and Depression Scale - Parent-Report
timeFrame: 7 days
measure: Clinical Global Impression - Improvement
timeFrame: 7 days
measure: Clinical Global Impression - Severity of Illness
timeFrame: 7 days
Secondary outcomes:
measure: Revised Children's Anxiety and Depression Scale - Self-Report
timeFrame: 7 days
measure: Pediatric Anxiety Rating Scale modified for Autism
timeFrame: 7 days
measure: Children's Depression Rating Scale, Revised
timeFrame: 7 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor Psychiatry Clinic
state: Texas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.