Clinical trial NCT05430022: Group Depression Treatment for Autistic Youth
Official title: Adapted Cognitive Behavioral Therapy for Depression in Autistic Youth: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Depression
Suicidal Ideation
Self Esteem
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 48
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pilot, nonrandomized trial of a behavioral intervention for autistic adolescents.
Primary purpose: TREATMENT

Brief summary: Higher rates of depression are reported by autistic adolescents as compared to their non-autistic peers, which is problematic given adverse outcomes (e.g., negative self-esteem, lower academic performance) that are associated with depression. Despite the alarming rates of depression in autistic youth and associated safety concerns, few treatments have been developed. In this study, we investigate the feasibility, acceptability, and preliminary efficacy of an autism-adapted group cognitive-behavioral treatment for autistic adolescents (11-17 years old; middle and high school) in a pilot, nonrandomized trial. Specifically, we aim to increase adolescents' perception and understanding of self, including autistic identity, in order to treat depression. Intervention design and implementation were guided by autistic self-advocates and parents.

Detailed description: Higher rates of depression and suicidal thoughts are reported by autistic adolescents as compared to their non-autistic peers, which is problematic given adverse outcomes (e.g., negative self-esteem, lower academic performance) that are associated with depression. Despite the alarming rates of depression in autistic youth, few interventions have been developed or tested to reduce depression in this at-risk population. An evidence-based intervention for depression in non-autistic adolescents is Cognitive Behavioral Therapy (CBT), which CBT has strong research support for treating depression in non-autistic adolescents according to the American Psychological Association (APA). Autism-adapted CBT programs for anxiety and OCD have outperformed standard CBT approaches for autistic youth; however, autism-adapted CBT programs for depression in autistic adolescents have not been developed with stakeholders nor tested in a clinical setting. To address this gap, an adapted CBT group intervention for autistic adolescents (11-17 years old; middle and high school) with depression was designed in collaboration with autistic stakeholders.

In the present study, the feasibility, acceptability, and preliminary efficacy of this 12-week group intervention in improving perception and understanding of self and depressive symptoms will be examined in a pilot, nonrandomized trial with pretest-posttest design. Groups will occur in the Outpatient Clinic of the Department of Psychiatry and Behavioral Sciences at the Vanderbilt University Medical Center (VUMC), and study measures will be administered to adolescents and their parents at four timepoints: baseline (week 0), midpoint (week 6), post (week 12), and follow-up (week 24). Study measures include parent- and self-report measures of adolescent well-being (e.g., perception of self, quality of life, etc.) and clinical interviews of psychiatric symptoms (e.g., depressive symptoms, suicidal thoughts). The significance and size of intervention effects on emotional and behavioral outcomes will be measured using one-way ANOVAs and linear mixed models. If predicted results occur, it will provide information on the feasibility and acceptability of this group intervention, with preliminary empirical support for its efficacy in improving perception and understanding of self and reducing the severity of depressive symptoms in autistic adolescents.

Eligibility criteria: Adolescent Inclusion Criteria:

* 11 to 17 years of age (middle or high school)
* Diagnosis of Autism Spectrum Disorder
* Average to above-average intellectual functioning
* Willing to attend study visits and participate in weekly group intervention

Adolescent Exclusion Criteria:

* No diagnosis of Autism Spectrum Disorder
* Comorbid intellectual impairment (FSIQ \< 70), as the study protocol and assessments are not designed, and thus not appropriate, for this population.
* Severe medical conditions (e.g., uncontrolled seizures) and/or genetic disorders (e.g., Fragile X syndrome).
* Unwilling to attend study visits or weekly group intervention sessions.
* Significant aggression to self/others
* Significant active suicidal thoughts with intent/plan requiring higher-level care

Parent Inclusion Criteria:

* At least 18 years of age and a parent or legal guardian of the adolescent participant with ASD.
* Able to provide current and historical observations of the functioning of the participant with ASD based on self report from parent. Similarly, parent must live in close proximity to and have frequent contact with the participant with ASD.
* Willing to complete questionnaires about their own functioning and that of their child with ASD.

Parent Exclusion Criteria:

-Parents of adolescents with ASD who do not have frequent contact with the participant with ASD and/or unable to provide current and historical observations of the functioning of the participant with ASD.

Primary outcomes:
measure: Change in Severity of Adolescent Depressive Symptoms, Self-report
timeFrame: Baseline to 6 months
measure: Change in Severity of Adolescent Depressive Symptoms, Parent-report
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jessica M Schwartzman, PhD
role: PRINCIPAL_INVESTIGATOR
References: