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临床试验/NCT02855008
NCT02855008已完成不适用

Steps to Effective Problem Solving in Group Homes for Individuals With Intellectual Disabilities

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2016年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
211
试验地点
1
主要终点
The IFIRS Dyadic-interaction scales

研究概览

简要总结

Aggressive/challenging behaviors in individuals with intellectual disability are a major public health concern for them, their families, their service programs and staff, and their communities. This randomized clinical trial will test the efficacy and cost effectiveness of a preventive community-based social problem solving intervention, the Steps to Effective Problem-solving (STEPS), delivered in group homes. The program uses residential staff participation and the group environment to facilitate improved social problem solving skills and reduce aggressive/challenging behaviors in this population in group homes and work settings.

详细描述

Aggressive/challenging behaviors (AC/Bs) are a major public health problem for individuals with intellectual disabilities (ID) living in group homes. A leading reason for psychiatric hospitalizations and incarcerations, A/CBs are costly to the healthcare system, agencies and families. Social problem solving (SPS) training programs for individuals with ID have had positive behavioral results, but most were conducted in clinical or forensic settings. None were community-based preventive interventions, none examined whether A/CBs decreased in participants' group homes and work settings, and none addressed cost effectiveness. In preliminary work, the investigators modified an effective SPS training program, using input from individuals with ID and residential staff, as a preventive intervention for the group home setting. Steps to Effective Problem-solving (STEPS) includes residential staff and uses the group home environment to facilitate behavior change. The purpose of this clinical trial is to test the efficacy of STEPS for individuals with ID. Specific aims are to 1) Assess the efficacy of the STEPS intervention in group homes to improve SPS skills and reduce A/CBs of the individuals with ID compared to an attention-control nutrition program from baseline to 12, 24 and 36 weeks, controlling for behavioral determinants of A/CBs (demographics, agency/home environment, current health). 2) Assess the mediating effect of the support environment for SPS (residential staff SPS skills, group home level SPS skills, and group cohesiveness) on the improvement of SPS skills and reductions in A/CBs. 3) Evaluate cost effectiveness of STEPS relative to usual care for A/CB incidents in group homes. The investigators expect to show STEPS to be a preventive behavioral strategy to reduce A/CBs among individuals with ID, improve the cost effectiveness of their care and make an important incremental advance in SPS research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
是

入选标准

  • 未提供

排除标准

  • •Inclusion criteria:
  • •Serve individuals with mild to moderate ID;
  • •Have at least 10 A/CB incident reports in resident files over the prior six-month period, with at least 30% of residents in each home having incident reports in that period
  • •Have 4 or more residents, with a minimum of 3 agreeing to participate
  • •Individuals with ID and residential staff all speak English
  • •Have at least one residential staff members who agree to participate.
  • •Exclusion criteria:
  • •If group home specifically serves individuals with ID who also have serious mental illness (e.g., severe autism, schizophrenia)
  • •If group home specifically serves forensic populations
  • •If the group home participated in previous preliminary study
  • •Individual with ID
  • •Inclusion criteria:
  • •Has mild to moderate ID (operationalized as IQ 50-75 per agency records) and mild to moderate limitations in adaptive functioning (measured by the Inventory for Client and Agency Planning used in all residential agencies in Illinois, per agency record)
  • •Lives in a chosen group home
  • •Is verbal and speaks English
  • •Exclusion Criteria:
  • •If individual does not meet inclusion criteria and
  • •If participated in the preliminary study
  • •Residential staff
  • •Inclusion criteria:
  • •Employed as residential staff in the chosen group homes and
  • •Speak and read English
  • •Exclusion criteria:
  • •Does not meet inclusion criteria
  • •Participated in the previous preliminary study.

研究组 & 干预措施

STEPS

Experimental

Experimental: Individuals with ID and residential staff in group homes receive 6 one-hour STEPS sessions over 12 weeks and a booster in week 18 following a standardized manual. Sessions include interactive games to build group cohesiveness, along with interactive discussion and practice. Participants are given session materials and 1-2 worksheets to practice learned skills and are asked to return the worksheets at the next session. Residential staff are given additional materials with tips on how to help residents practice social problem-solving skills between sessions. Highlights of each session using a standardized format are brought to the following session to help with engagement and provide cues for retention of materials.

干预措施: STEPS (Behavioral)

Food for Life

Active Comparator

Active Comparator: Individuals with ID and residential staff in group homes receive 6 one-hour Food for Life sessions over 12 weeks and a booster in week 18 following a standardized manual. Sessions include interactive games regarding food and nutrition followed, along with interactive discussion and practice. Participants are given session materials and 1-2 worksheets to practice learned skills and are asked to return the worksheets at the next session. Residential staff are given additional materials with tips on how to help residents practice Food for Life skills between sessions. Highlights of each session using a standardized format are brought to the following session to help with engagement and provide cues for retention of materials.

干预措施: Food for Life (Behavioral)

结局指标

主要结局

The IFIRS Dyadic-interaction scales

时间窗: Baseline, 12 and 24 weeks

Change from baseline Individual with ID Behaviors: Uses the same 15-20 minute videotape of a problem-solving interaction to assess individual with ID A/CBs. Items include hostility, verbal attack, physical attack, contempt, etc. (total 22 items) of each individual with ID

Problem-solving Task (PST)

时间窗: Baseline, 12, and 24 weeks

Change from baseline Individual with ID SPS: Has four questions on each of five problem vignettes that measure individual with ID SPS skills. The vignettes are read by data collectors to the individuals and responses audiotaped.

The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales

时间窗: Baseline, 12, and 24 weeks

Change from baseline Individual with ID SPS: Uses a 15-20 minute videotape of a problem-solving interaction of the group of individuals with ID living in the group home and their residential staff to assess individuals with ID SPS skills - solution quantity, solution quality, effective process, disruptive process, and negotiation/compromise at the individual level.

Agency incident reports

时间窗: For 24 weeks prior to intervention, 12, 24 and 36 weeks

Change from baseline Individual with ID behaviors: Residential staff members fill out incident reports. The reports are reviewed by QIDPs, kept in resident files, and tracked by the agencies. Data will be abstracted from agency tracking records and de-identified. The investigators will analyze counts of incidents for outcomes and summarize descriptive data of key elements of the incident reports.

General Maladaptive Index

时间窗: Baseline, 12 and 24 weeks

Change from baseline Individual with ID Behaviors: Qualified Intellectual Disability Professionals (QIDPs) at the residential agency and work setting supervisors (sheltered workshops and employment) will be asked to fill out the GMI on participants with ID. The GMI measures the frequency (0 = never to 5 = one or more times an hour) and severity (0 = not serious to 4 = extremely serious) of problem behaviors in eight domains (hurtful to self or others, destructive, disruptive, socially offensive, unusual/repetitive, withdrawn/inattentive, uncooperative).

次要结局

  • IFIRS Group Problem-solving Scales(Baseline,12 and 24 weeks)
  • Social Problem Solving Inventory Revised - Short form (SPSI-R SF)(Baseline, 12 and 24 weeks)
  • Group Environment for the Intervention Scale (GEIS)(Week 1 and 12)
  • The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales(Baseline,12 and 24 weeks)

研究者

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

Sarah Ailey

Professor

Rush University Medical Center

研究点 (1)

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