Clinical trial NCT05030610: Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults
Official title: Treating Depression in Autistic Adults: A Feasibility Trial of an Adapted Behavioral Activation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Depression
Depressive Symptoms
Keywords: behavioral activation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Governor's Council for Medical Research and Treatment of Autism
First posted: 2021-09-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in distress on Patient Health Questionnaire (PHQ-9)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Change in distress on Glasgow Depression Scale (GDS)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Change in distress on Anxiety Depression and Mood Scale (ADAMS)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Change on Adult Behavior Checklist (ABCL)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Change on Adult Self Report (ASR)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Change in frequency of activities on Index of Community Involvement (ICI)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Change in frequency of activities on Index of Participation in Domestic Life (IPDL)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Change in behavioral activation on Behavioral Activation for Depression Scale (BADS)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Secondary outcomes:
measure: Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Change in quality of life on Shalock Quality of Life Questionnaire
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University - New Brunswick
state: New Jersey
Study officials:
affiliation: Rutgers University - New Brunswick
name: Vanessa H Bal, PhD
role: PRINCIPAL_INVESTIGATOR
References: