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Clinical Trials/NCT02855008
NCT02855008
Completed
Not Applicable

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

Rush University Medical Center1 site in 1 country211 target enrollmentSeptember 7, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Problem Behavior
Sponsor
Rush University Medical Center
Enrollment
211
Locations
1
Primary Endpoint
Problem-solving Task (PST)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2016
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Ailey

Professor

Rush University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Problem-solving Task (PST)

Time Frame: 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

Time Frame: 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

Time Frame: 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.

The IFIRS Dyadic-interaction scales

Time Frame: 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

General Maladaptive Index

Time Frame: 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).

Secondary Outcomes

  • 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)

Study Sites (1)

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