Transdiagnostic Group Behavioral Activation for Autistic Adults

NCT04788212 | Completed

• 1 other identifier: Pro2020001634
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a telehealth Group Behavioral Activation Therapy (GBAT) for autistic adults.

Conditions

Autism Spectrum Disorder; Depression, Anxiety; Anxiety; Anger

Outcome Measures

Primary Outcomes (2)

• Change in symptoms on the Adult Self Report (ASR)

  The ASR is a an assessment of adult psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.

  10 week study period; 4 week post-treatment

• Change in Clinician Global Impairment rating

  The CGI is a 7 point scale on which the clinician rates the severity of the client's impairment. The scale ranges from 1 (Normal, not at all ill) to 7 Extremely Ill; higher scores indicate more impairment.

  10 week study period;

Secondary Outcomes (6)

• Change in symptoms on the Depression Anxiety Stress Scales-21

  10 week study period; 4 week post-treatment

• Change in distress on Patient Health Questionnaire (PHQ-9)

  10 week study period

• Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)

  10 week study period

• Change in Adaptive Behavior Assessment System - 3 (ABAS-3)

  10 week study period

• Change in Behavioral Activation for Depression Scale

  10 week study period; 4 week post-treatment

Study Arms (1)

GBAT

EXPERIMENTAL

10-week behavioral activation treatment group.

Behavioral: Group Behavioral Activation Therapy for Autism Spectrum Disorder

Interventions

Group Behavioral Activation Therapy for Autism Spectrum Disorder BEHAVIORAL

This will be a modification of the Group Behavioral Activation Therapy program (Chu et al., 2009) for treatment of depression, anxiety and/or anger in autistic adults.

GBAT

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be 18-40 years old
• Have a confirmed diagnosis of Autism Spectrum Disorders (ASD).
• Have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in the telehealth videoconferencing sessions
• \*Have a VIQ and NVIQ of 85 or above
• \*Have at least a 6th grade reading composite
• \*Have elevated symptoms of depression, anxiety or anger. This will be determined based on scoring above the borderline or mild threshold on at least one of 3 screening measures (MINI; ASR; DASS-21).

You may not qualify if:

• Are younger than 18 years old, or older than 40 years old (Children are excluded because the focus is on adapting GBAT for adults; Individuals above 40 are excluded to restrict the adult focus to young adults that are more likely to be in similar life stages).
• Do not have an ASD diagnosis (because the study as the purpose of the current research is to examine GBAT's feasibility with autistic adults).
• Both VIQ and NVIQ below 85 OR less than 6th grade reading level
• Do not have elevated scores of depression, anxiety, or anger on the symptom screening measures.
• Are unable to understand English fluently (because the instruments being investigated are currently only validated in English and the intervention will be delivered in English).
• Are currently enrolled in another behavioral therapy or psychotherapy targeting depression,
• the PI's clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open trial feasibility study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karmazin & Lillard Chair in Adult Autism; Associate Professor

Model Details: 8 participants with autism and depression, anxiety or anger will participate

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: February 16, 2021
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)