Clinical trial NCT02855008: Steps to Effective Problem Solving in Group Homes
Official title: Steps to Effective Problem Solving in Group Homes for Individuals With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem Behavior
Keywords: Social Problem-Solving
Intellectual Disability
Problem Behaviors
Community based intervention
Prevention
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-08-04
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales
timeFrame: Baseline, 12, and 24 weeks
measure: Problem-solving Task (PST)
timeFrame: Baseline, 12, and 24 weeks
measure: The IFIRS Dyadic-interaction scales
timeFrame: Baseline, 12 and 24 weeks
measure: General Maladaptive Index
timeFrame: Baseline, 12 and 24 weeks
measure: Agency incident reports
timeFrame: For 24 weeks prior to intervention, 12, 24 and 36 weeks
Secondary outcomes:
measure: The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales
timeFrame: Baseline,12 and 24 weeks
measure: Social Problem Solving Inventory Revised - Short form (SPSI-R SF)
timeFrame: Baseline, 12 and 24 weeks
measure: IFIRS Group Problem-solving Scales
timeFrame: Baseline,12 and 24 weeks
measure: Group Environment for the Intervention Scale (GEIS)
timeFrame: Week 1 and 12
Other outcomes:
measure: Life events section of Psychiatric Assessment Schedule for Adults with Developmental Disabilities
timeFrame: Baseline, 12 and 24 weeks
measure: Glasgow Depression Scale for People with Learning Disabilities [GDS-LD])
timeFrame: Baseline, 12 and 24 weeks
measure: Medication management
timeFrame: Baseline, 12 and 24 weeks
measure: A/CB incident costs
timeFrame: 12-36 weeks
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Sarah H Ailey, PhD RN
role: PRINCIPAL_INVESTIGATOR
References: