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

Depression Clinical Trial

Official title:

Treating Depression in Autistic Adults: A Feasibility Trial of an Adapted Behavioral Activation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030610
• Other study ID #: Pro2021001254
• Status: Completed
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: December 7, 2022

Study information

• Verified date: March 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Depression
• Depressive Disorder
• Depressive Symptoms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Rutgers University - New Brunswick	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Governor's Council for Medical Research and Treatment of Autism

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in distress on Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a 9-item self-reported questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress. The PHQ-9 is administered to those without intellectual disability.	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Primary	Change in distress on Glasgow Depression Scale (GDS)	The GDS is a 20-item self- and caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. The GDS is administered to those with intellectual disability.	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Primary	Change in distress on Anxiety Depression and Mood Scale (ADAMS)	The ADAMS is a 20-item caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. The ADAMS is administered to those with intellectual disability.	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Primary	Change on Adult Behavior Checklist (ABCL)	The ABCL is a caregiver-report measure of adaptive functioning and 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. Higher scores equal more symptoms.	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Primary	Change on Adult Self Report (ASR)	The ASR is a self-reported measure of adaptive functioning and 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. Higher scores equal more symptoms.	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Primary	Change in frequency of activities on Index of Community Involvement (ICI)	The ICI is a 48-item self- and caregiver-reported measure of community involvement over the previous month. All items on the measure ask the frequency of participating in activity from 0 (Never) to 5 (Daily).	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Primary	Change in frequency of activities on Index of Participation in Domestic Life (IPDL)	The IPDL is an 18-item self- and caregiver-reported measure of participation in domestic activities over the previous month. All items on the measure ask in what manner a participant completed domestic activities from 0 (Did alone without prompting) to 2 (Did not do).	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Primary	Change in behavioral activation on Behavioral Activation for Depression Scale (BADS)	The BADS is a 25-item self-reported measure of behaviors and thoughts related to depression. All items on the measure ask the participant to rate how much each statement describes them from 0 (not at all) to 6.	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Secondary	Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)	The VABS-3 is a 381-item caregiver-reported measure of adaptive behavior. All items in the measure ask the frequency at which the participants performs a behavior, from 0 (never) to 2 (usually).	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Secondary	Change in quality of life on Shalock Quality of Life Questionnaire	The Shalock Quality of Life Questionnaire is a 40-item self- and caregiver-reported measure of quality of life. Each question prompts the informant to choose one of three options (differing by item) based on which seems most appropriate to them.	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)