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临床试验/NCT05030610
NCT05030610已完成不适用

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

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Change in distress on Anxiety Depression and Mood Scale (ADAMS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have a confirmed diagnosis of Autism Spectrum Disorders (ASD)
  • 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).
  • Have a support person willing to participate
  • Live in New Jersey or New York, or be within travel distance to Rutgers University
  • 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.

排除标准

  • 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).
  • Are currently enrolled in another behavioral therapy or psychotherapy targeting depression. Participants will not be excluded if they are currently taking medication.

结局指标

主要结局

Change in distress on Anxiety Depression and Mood Scale (ADAMS)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

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.

Change on Adult Self Report (ASR)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

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.

Change in behavioral activation on Behavioral Activation for Depression Scale (BADS)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

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.

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

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

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.

Change in frequency of activities on Index of Community Involvement (ICI)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

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).

Change in distress on Glasgow Depression Scale (GDS)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

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.

Change on Adult Behavior Checklist (ABCL)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

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.

Change in frequency of activities on Index of Participation in Domestic Life (IPDL)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

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).

次要结局

  • Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)(Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up))
  • Change in quality of life on Shalock Quality of Life Questionnaire(Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa H. Bal, PhD

Associate Professor; Karmazin & Lillard Chair in Adult Autism

Rutgers, The State University of New Jersey

研究点 (2)

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