Group Depression Treatment for Autistic Youth

NCT ID: NCT05430022

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2023-04-03

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.

Conditions

Autism Spectrum Disorder; Depression; Suicidal Ideation; Self Esteem

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings)

Autistic adolescents (11-17 years old; middle and high school) with depression will participate in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to increase perception and understanding of self and to decrease the severity of depressive symptoms.

Group Type: EXPERIMENTAL

Autism-adapted Group Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic stakeholders (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.

Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings)

One parent of each autistic adolescent (11-17 years old; middle and high school) with depression will provide ratings of their child as their child participates in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Parents will not participate in therapy sessions.

Group Type: EXPERIMENTAL

Autism-adapted Group Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic stakeholders (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.

Interventions

Autism-adapted Group Cognitive Behavioral Therapy

The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic stakeholders (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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.

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

-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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jessica Schwartzman, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica M Schwartzman, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

201725

Identifier Type: -

Identifier Source: org_study_id