Protect Yourself: Abuse Prevention for People With Intellectual Disabilities

NCT03998605 | Withdrawn

• 2 other identifiers: AbusePhaseIIR44HD079119-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to help individuals and their caregivers develop a plan on how to recognize, deal with and respond to abusive situations.

Conditions

Abuse Prevention

Keywords

intellectual disabilities; abuse; abuse prevention

Outcome Measures

Primary Outcomes (2)

• Abuse Protection Concept Questionnaire

  This questionnaire assesses change in knowledge and attitude about various types of abuse in individuals with Intellectual Disability (ID). The questionnaire includes three sub scales. The first sub-scale is comprised of five open ended questions. Score answers range from 0 to 3 with a total score of 15. Higher scores reflect higher knowledge. The second sub-scale presents structured questions about the five types of abuse. The total possible score for the first part of the second sub-scale is 5 -- with higher score reflecting greater knowledge. Participants are then shown five pictures depicting types of abuse. Each correct response was awarded a point for a total of five. The total possible score for sub-sale 2 is 10. Sub-scale 3 is a 20 item forced choice -- yes (1) , no (0), don't know (0) - that assesses knowledge and attitudes. with a total possible sub-score of 20 -- higher score equals higher knowledge.

  Pre, post (9 weeks), and 2 month follow-up

• Abuse Protection Decision Making and Task Analysis Check Sheet

  This checklist assesses change in knowledge required by people with ID to recognize and report abuse. It consists of five vignettes of abusive situations and two non-abusive. Each vignette has a a possible score of 10. The total possible score for all seven vignettes is 70 with higher scores reflecting greater knowledge.

  Pre, post (9 weeks), and 2 month follow-up

Secondary Outcomes (3)

• Glascow Social Self-Efficacy Scale

  Pre, post (9 weeks), and 2 month follow-up

• Test of Interpersonal Competence and Personal Vulnerability

  Pre, post (9 weeks), and 2 month follow-up

• Social Vulnerability Questionnaire

  Pre, post (9 weeks), and 2 month follow-up

Other Outcomes (2)

• Adults with ID Consumer Satisfaction

  Post (9 weeks)

• Learning Partner Consumer Satisfaction

  Post (9 weeks)

Study Arms (2)

Abuse Prevention Program Condition

EXPERIMENTAL

The abuse prevention program will address: (1) BEFORE -- (a) Learning about problem of abuse and what abuse is; (b) Knowing about types of abuse, who the abusers are and where abuse happens; (c) Planning ahead and identifying safe people; (2) DURING -- (a) Rejecting abuse by saying "no;" (b) Getting away if possible/staying safe and paying attention, (c) Staying calm and getting home; and (3) AFTER -- (a) Telling your safe person, (b) Knowing what to do and what not to do, and (c) Reporting the abuse and getting help to cope with the event.

Behavioral: Abuse Prevention Program

Control condition

ACTIVE COMPARATOR

During the study the control group will receive 12 activity sheets from the ESCAPE-NOW curriculum. Six activity sheets will be given at the initial meeting and half way through the study the remaining activity sheets will be mailed to the dyads. We chose these activity sheets because they provide abuse information that was designed for individuals with ID.

Behavioral: Control Condition

Interventions

Abuse Prevention Program BEHAVIORAL

The abuse prevention program will be comprised of nine shared learning modules for the individual with Intellectual Disabilities (ID) and a care provider. Each shared module will contain an action step in the Individual Response Plan and will include video, guided practice and workbook activities to equip persons with ID with a range of judgment, decision-making skills and the efficacy needed for identifying, rejecting, and reporting abuse.

Abuse Prevention Program Condition

Control Condition BEHAVIORAL

The control group will receive worksheets from the ESCAPE-NOW curriculum.

Control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has moderate to mild mental retardation based on IQ scores ranging from 40-70
• is over 18 years old. --the participant must be able to do three of the following four skills (1) complete a simple worksheet with assistance, (2) go on simple errands alone, (3) recognize 10 or more words by site, (4) read a digital clock.

You may not qualify if:

• individuals who have experienced traumatic abuse and experiences symptoms suggestive of trauma, such as flashbacks, nightmares, and chronic anxiety and/or depression that is resistant to standard pharmacological and psychotherapy/behavior interventions.

Sponsors & Collaborators

• Double S Instructonal Systems: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Double S Instructional Systems

Eugene, Oregon, 97405, United States

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin R. Sheehan, Ph.D.

  Research Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: June 26, 2019
• Study Start: October 4, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent reviewer. Requestors will be required to sign a data access agreement.

Locations

US (1)