Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults

NCT ID: NCT05030610

Last Updated: 2023-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2022-12-07

Brief Summary

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The present study aims to adapt and evaluate the feasibility of the BeatIt behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with autistic individuals, with and without intellectual disabilities.

Detailed Description

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The study has two specific aims:

1. Adapt BeatIt materials for use with autistic adults with and without Intellectual Disability (ID). Focus groups engaging key stakeholders will inform the adaptation of BeatIt for autistic adults (i.e., BeatIt-ASD). A stakeholder advisory team will provide input through the duration of the study.
2. Evaluate the feasibility, acceptability, and preliminary efficacy of BeatIt-ASD for autistic adults. This includes examining if the data demonstrate the feasibility and acceptability of the BeatIt-ASD program for autistic adults and provide preliminary evidence for behavioral change (i.e., increased engagement in meaningful activities and reduced depressive symptoms).

Data will demonstrate the feasibility and acceptability of the adapted BeatIt intervention for autistic adults and provide preliminary evidence for reduction of depression symptoms via regulation of routines and achievement of meaningful goals.

Conditions

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Autism Spectrum Disorder Depression Depressive Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants, along with a support person, will complete 12 weekly sessions of the BeatIt-ASD intervention. The support person will complete an initial session before commencement of the 12 weekly sessions.

Group Type EXPERIMENTAL

BeatIt-ASD

Intervention Type BEHAVIORAL

BeatIt-ASD, designed to be implemented with autistic individuals, is an adaptation of BeatIt. The intervention aims to improve mood and decrease depressive symptoms through an increase in meaningful engagement in recreational, domestic, and social/leisure activities.

Interventions

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BeatIt-ASD

BeatIt-ASD, designed to be implemented with autistic individuals, is an adaptation of BeatIt. The intervention aims to improve mood and decrease depressive symptoms through an increase in meaningful engagement in recreational, domestic, and social/leisure activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Have a confirmed diagnosis of Autism Spectrum Disorders (ASD)
2. Have a best estimate diagnosis of clinically significant depressive symptoms by the study team. This will be based on DSM-5 criteria or DM-ID (Diagnostic Manual - Intellectual Disability).
3. Have a support person willing to participate
4. Live in New Jersey or New York, or be within travel distance to Rutgers University
5. Half of participants will have a best estimate diagnosis of mild to moderate intellectual disability and half will not have intellectual disability. This will be based on participant cognitive assessment and self and/or supporter report of adaptive function during the Baseline visit.

Exclusion Criteria

1. Are unable to speak and understand English fluently (because the instruments being investigated are currently only validated in English and the focus group and intervention will be delivered in English).
2. Are currently enrolled in another behavioral therapy or psychotherapy targeting depression. Participants will not be excluded if they are currently taking medication.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Governor's Council for Medical Research and Treatment of Autism

UNKNOWN

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Vanessa H. Bal, PhD

Associate Professor; Karmazin & Lillard Chair in Adult Autism

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanessa H Bal, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University - New Brunswick

Locations

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Rutgers University - New Brunswick

Piscataway, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Pro2021001254

Identifier Type: -

Identifier Source: org_study_id

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