Steps to Effective Problem Solving in Group Homes

Problem Behavior Clinical Trial

— STEPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855008
• Other study ID #: R01HD086211
• Secondary ID: 1R01HD086211-01A
• Status: Completed
• Phase: N/A
• Start date: September 7, 2016
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: October 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intellectual Disability
• Problem Behavior

Intervention

Behavioral:
• STEPS
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.
• Food for Life
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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Life events section of Psychiatric Assessment Schedule for Adults with Developmental Disabilities	Change from baseline in A/CB determinant of life events: (17 items 2-recent 1-event 0-never)	Baseline, 12 and 24 weeks
Other	Glasgow Depression Scale for People with Learning Disabilities [GDS-LD])	Change from baseline of A/CB determinant depression. The GDS-LD was developed for use among individuals with ID (called "learning disabilities" in the UK). It has a sensitivity ranging from 90-96% and specificity ranging from 83.9-90%, with a score of 13.	Baseline, 12 and 24 weeks
Other	Medication management	Background information on psychotropic medications will be gathered from agency records	Baseline, 12 and 24 weeks
Other	A/CB incident costs	Compare A/CB incident costs for experimental arm vs. active comparator arm. The investigators will evaluate the cost-effectiveness of STEPS from the societal perspective, taking into account costs borne by the program, group home, health care system, public services, participant, and family. The STEPS experimental arm group will be compared to usual care (active comparator Food for Life) group costs of A/CBs excluding costs of the nutrition intervention). We will calculate the net cost (or net savings) associated with STEPS vs. Food for Life arms, such that the net cost = program-related cost - A/CB incident cost	12-36 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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