Transdiagnostic Group Therapy (GBAT) for Autistic Adults With Personalized Therapeutics

NCT05512221 | Completed

• 1 other identifier: Pro2022001343
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to build upon an earlier study that evaluated the use of a 10-week transdiagnostic Group Behavioral Activation Therapy (GBAT), a telehealth delivered intervention, as a cost effective and accessible way to treat symptoms of anxiety and depression in autistic adults. The current study will pilot and compare relative feasibility, acceptability, and preliminary efficacy of three adapted GBAT groups and a Watchful Waiting (WW) group. The three groups include GBAT+Individual (GBAT+I; individual sessions to supplement the 10 group sessions), GBAT+Engagement Booster (GBAT+E; supplemental materials), and GBAT+Both (GBAT+IE individual sessions and supplemental materials).

Conditions

GBAT+Individual; GBAT+Engagement Booster; GBAT+Both

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator

  The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill), while the CGI-I provides a global rating of clinical improvement ranging from 1 (Very Much Improved) to 7 (Very Much Worse). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment.

  Change from pre-treatment to post-treatment (an average of 12 weeks)

Secondary Outcomes (6)

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

  Change from pre-treatment to post-treatment (an average of 12 weeks)

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

  Change from pre-treatment to post-treatment (an average of 12 weeks)

• Anxiety Disorders Interview Schedule for DSM-5

  Change in CSR from pre-treatment to post-treatment (an average of 12 weeks)

• Behavior Rating Inventory of Executive Function - Adult Form

  Change from pre-treatment to post-treatment (an average of 12 weeks)

• Mirror Tracing Persistence Task

  Change from pre-treatment to post-treatment (an average of 12 weeks)

Study Arms (3)

Phase I

EXPERIMENTAL

GBAT+I and GBAT+E groups

Other: GBAT+I, GBAT+E - Phase I

Phase 2a

EXPERIMENTAL

Watchful Waiting, GBAT+I, and GBAT+E groups

Other: Watchful Waiting and Groups - Phase 2

Phase 2b

EXPERIMENTAL

GBAT+IE groups

Other: GBAT+IE

Interventions

GBAT+I, GBAT+E - Phase I OTHER

Phase I is the development phase, which is informed by the study team's previous pilot study and autistic advisors. It will include the development of engagement booster materials. Booster materials will be tested in 2 groups (GBAT+I and GBAT+E) of six participants each. Groups include GBAT+Individual (GBAT+I; individual sessions to supplement the 10 group sessions) and GBAT+Engagement Booster (GBAT+E; supplemental materials). The first 4-6 eligible adults recruited will participate in GBAT+I and the second 6 eligible adults recruited will participate in GBAT+E. Both groups will consist of 10 weekly 60-90-minute GBAT group sessions. Participants in the GBAT+I group will also attend 30-minute individual booster sessions, approximately between Weeks 4-5, 5-6, 6-7, and 7-8. Participants in the GBAT+E group will be asked to use booster materials in between group sessions (e.g., worksheets, goal trackers, interactive learning activities).

Phase I

Watchful Waiting and Groups - Phase 2 OTHER

Phase 2a will include a watchful waiting (WW) condition and assignment to 1 of 2 treatment conditions: GBAT+I or GBAT+E. Participants will be assigned to WW for 10 wks. They will not receive specific therapeutic services during WW, but a member of the study team will contact them at weeks 1, 2, 4, 6, and 8 to maintain engagement and monitor for clinical deterioration. After WW, participants will be randomly assigned to one of the treatment conditions (GBAT+I or GBAT+E). All groups will consist of 10 weekly 60-90-minute GBAT group sessions. GBAT+I participants will attend four 30-minute individual booster sessions. GBAT+E participants will be asked to use booster materials between group sessions (e.g., worksheets, goal trackers, interactive learning activities) WW group size is based on study feasibility and availability of resources. Additional participants will also be recruited at the end of the WW period to supplement group sizes.

Phase 2a

GBAT+IE OTHER

Phase 2b will include assignment to GBAT+IE, which includes components of both GBAT+I (individual sessions) and GBAT+E (supplemental materials) All groups will consist of 10 weekly 60-90-minute GBAT group sessions. Participants in the GBAT+I group will also attend 30-minute individual booster sessions, approximately between Weeks 4-5, 5-6, 6-7, and 7-8. Participants in the GBAT+E group will be asked to use booster materials in between group sessions (e.g., worksheets, goal trackers, interactive learning activities). Participants in GBAT+IE will participate in both the individual sessions and use of booster materials.

Phase 2b

Eligibility Criteria

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

You may qualify if:

• Live in New Jersey or New York
• 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 videoconference sessions
• WRAT Reading Comprehension grade equivalent 6th grade or higher
• Receive a best-estimate diagnosis of an anxiety or mood disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Specific Phobia, Panic Disorder, Agoraphobia, Major Depressive Disorder, Unspecified Depression, Persistent Depressive Disorder).
• Be interested in participating in an online telehealth treatment group to address their difficulties in the aforementioned areas
• Approximately 60% of our sample will be White, Non-Hispanic; approximately 40% of our sample will be female-identifying and 40% will be male-identifying

You may not qualify if:

• Are younger than 18 years old, or older than 40 years old
• Do not have an ASD diagnosis
• Have WRAT Reading Comprehension below 6th grade level
• Are unable to understand English fluently
• Have a principal DSM-5 disorder other than one of the above listed anxiety or depression disorders, have received a diagnosis of Intellectual Disability, schizophrenia, or bipolar disorder or demonstrate suicidal ideation or intent severe enough to require current hospitalization, or who have attempted suicide in the past 3 months.
• Are currently enrolled in another behavioral therapy or psychotherapy targeting depression, anxiety or anger.
• Are experiencing suicidal ideation that requires current hospitalization.
• The PI's best 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
• New Jersey Governor's Council for Medical Research and Treatment of Autism: collaborator

Study Sites (1)

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Vanessa Bal, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Karmazin and Lillard Chair in Adult Autism

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 23, 2022
• Study Start: September 23, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)