Clinical trial NCT03998605: Protect Yourself: Abuse Prevention for People With Intellectual Disabilities
Official title: Protect Yourself: Abuse Prevention for People With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abuse Prevention
Keywords: intellectual disabilities
abuse
abuse prevention
Lead sponsor: Double S Instructonal Systems
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The goal of this project is to address the current deficiencies by creating a program that will guide individuals who have intellectual disabilities and a Learning Partner (LP - care provider, relative, group home staff) in developing a comprehensive Individual Response Plan (IRP) that can be used before, during, and after an abusive event. Behavioral skills training and behavioral relaxation training -- two instructional approaches with evidence for effectiveness in this population -- will be included to address the unique learning needs of people who have intellectual disabilities and to maximize opportunities for skill-based learning. Video and workbook activities will train the LP to effectively implement the abuse prevention and response strategies, thus increasing the potential for generalization in the natural environment and long-term maintenance of skills.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Abuse Protection Concept Questionnaire
timeFrame: Pre, post (9 weeks), and 2 month follow-up
measure: Abuse Protection Decision Making and Task Analysis Check Sheet
timeFrame: Pre, post (9 weeks), and 2 month follow-up
Secondary outcomes:
measure: Glascow Social Self-Efficacy Scale
timeFrame: Pre, post (9 weeks), and 2 month follow-up
measure: Test of Interpersonal Competence and Personal Vulnerability
timeFrame: Pre, post (9 weeks), and 2 month follow-up
measure: Social Vulnerability Questionnaire
timeFrame: Pre, post (9 weeks), and 2 month follow-up
Other outcomes:
measure: Adults with ID Consumer Satisfaction
timeFrame: Post (9 weeks)
measure: Learning Partner Consumer Satisfaction
timeFrame: Post (9 weeks)
Locations:
city: Eugene
country: United States
facility: Double S Instructional Systems
state: Oregon
Study officials:
affiliation: Research Director
name: Martin R. Sheehan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: