Steps to Effective Problem Solving in Group Homes

NCT02855008 | Completed DMC

• 2 other identifiers: R01HD0862111R01HD086211-01A1
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Problem Behavior

Keywords

Social Problem-Solving; Intellectual Disability; Problem Behaviors; Community based intervention; Prevention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales

  Baseline,12 and 24 weeks

• Social Problem Solving Inventory Revised - Short form (SPSI-R SF)

  Baseline, 12 and 24 weeks

• IFIRS Group Problem-solving Scales

  Baseline,12 and 24 weeks

• Group Environment for the Intervention Scale (GEIS)

  Week 1 and 12

Other Outcomes (4)

• Life events section of Psychiatric Assessment Schedule for Adults with Developmental Disabilities

  Baseline, 12 and 24 weeks

• Glasgow Depression Scale for People with Learning Disabilities [GDS-LD])

  Baseline, 12 and 24 weeks

• Medication management

  Baseline, 12 and 24 weeks

Study Arms (2)

STEPS

EXPERIMENTAL

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

Food for Life

ACTIVE COMPARATOR

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

Interventions

STEPS BEHAVIORAL

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.

STEPS

Food for Life BEHAVIORAL

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.

Food for Life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Group home
• 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.
• 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
• 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
• If participated in the preliminary study
• Residential staff

Sponsors & Collaborators

• Rush University Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Problem Behavior; Intellectual Disability

Interventions

Food

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sarah H Ailey, PhD RN

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 4, 2016
• Study Start: September 7, 2016
• Primary Completion: May 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study protocol and informed consent can be shared now. Expect to share preliminary results Fall '22
• Access Criteria: Other researchers

Locations

US (1)