Steps to Effective Problem Solving in Group Homes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Problem Behavior

Intervention / Treatment
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* Behavioral: STEPS
* Behavioral: Food for Life


Participation Criteria
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Eligibility Criteria
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Inclusion/exclusion criteria Group home 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEPS<br>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. | Behavioral: STEPS<br>* Agencies providing residential services to individuals with ID gave us letters of agreement (N=9) when we submitted for funding. We randomized these agencies and followed the specific order. Over the past year, recruitment issues have resulted in our only being able to recruit at six of the original nine agencies. To address the issues, we compiled a list of 15 additional local agencies within a 50 mile radius. We are recruiting from an additional six agencies and are in contact with another four. We also changed our recruitment criteria to include co-ed homes. Within each agency we then, (1) determine homes that that meet criteria and, by gender (male, female, co-ed), randomize to STEPS or attention-control condition. Residential staff are consented first. Individuals with ID (or guardians if they have one) are then consented. 18 homes will participate in STEPS.<br>|
| Active Comparator: Food for Life<br>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. | Behavioral: Food for Life<br>* Agencies providing residential services to individuals with ID gave us letters of agreement (N=9) when we submitted for funding. We randomized these agencies and followed the specific order. Over the past year, recruitment issues have resulted in our only being able to recruit at six of the original nine agencies. To address the issues, we compiled a list of 15 additional local agencies within a 50 mile radius We are recruiting from an additional six agencies and are in contact with another four. We also changed our recruitment criteria to include co-ed homes. Within each agency we then, (1) determine homes that that meet criteria and, by gender (male, female, co-ed), randomize to STEPS or attention-control condition. Individuals with ID and staff are recruited after randomization. Residential staff are consented first. Individuals with ID (or guardians if they have one) are then consented. 18 homes will participate in Food for Life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales | 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. | Baseline, 12, and 24 weeks | 
| Problem-solving Task (PST) | 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. | Baseline, 12, and 24 weeks | 
| The IFIRS Dyadic-interaction scales | 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 | Baseline, 12 and 24 weeks | 
| General Maladaptive Index | 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). | Baseline, 12 and 24 weeks | 
| Agency incident reports | 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. | For 24 weeks prior to intervention, 12, 24 and 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales | Change from baseline Residential staff SPS (Support environment for Individual with ID). Uses the same 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 residential staff SPS skills - solution quantity, solution quality, effective process, disruptive process, and negotiation/compromise at the individual level. | Baseline,12 and 24 weeks | 
| Social Problem Solving Inventory Revised - Short form (SPSI-R SF) | Change from baseline Residential staff SPS (Support environment for Individual with ID). The five dimensions of this measure are positive attitude, negative attitude, rational style, impulsive/careless style, and avoidant style. | Baseline, 12 and 24 weeks | 
| IFIRS Group Problem-solving Scales | Change from baseline of Group (of individuals with ID and their residential staff) SPS (Support environment for Individual with ID). The scales include problem-solving enjoyment, agreement on problem description/solution, implementation, and problem difficulty for group, | Baseline,12 and 24 weeks | 
| Group Environment for the Intervention Scale (GEIS) | Change from baseline of group environment - cohesiveness (Support environment of individual with ID). The GEIS is a 25-item measure of group environments. The three subscales are implementation and preparedness, counter-productive activity, and cohesiveness. The GEIS will be scored using audiotapes from Sessions 1 and 6 by trained research assistants. | Week 1 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Problem-Solving, Intellectual Disability, Problem Behaviors, Community based intervention, Prevention