Problem Behavior Clinical Trial
— STEPSOfficial title:
Steps to Effective Problem Solving in Group Homes for Individuals With Intellectual Disabilities
Verified date | November 2022 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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 |
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