Abuse Prevention Clinical Trial
— AP4IDOfficial title:
Protect Yourself: Abuse Prevention for People With Intellectual Disabilities
| Verified date | February 2023 |
| Source | Double S Instructonal Systems |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 31, 2022 |
| Est. primary completion date | November 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Double S Instructional Systems | Eugene | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Double S Instructonal Systems | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adults with ID Consumer Satisfaction | This consumer satisfaction scale for people with ID consists of 15 items and 1 open-ended question that assesses relevance and clarity of materials and program use barriers. The 15 items are rated on a three point scale -1= not at all; 2= somewhat; and 3= a lot. The total possible score was 45. Higher scores reflect greater satisfaction with the program. | Post (9 weeks) | |
| Other | Learning Partner Consumer Satisfaction | This consumer satisfaction scale for the care giver (Learning Partner) consists of 31 items, and 1 open-ended question to assess usability and effectiveness of materials. The five point scale ranged from 1= strongly agree to 5= strongly disagree. The total possible score was 155 with lower scores reflecting greater satisfaction with the program. | Post (9 weeks) | |
| Primary | 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 | |
| Primary | 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 | Glascow Social Self-Efficacy Scale | Change in social self-efficacy in people with moderate to mild intellectual disabilities as measured by the 17-item self-efficacy scale. A three point response format is used to answer each question: not at all, a little bit, or a lot. Responses are scored 0,1, and 2 respectively giving a range of 0-34. Higher values represent better outcomes. | Pre, post (9 weeks), and 2 month follow-up | |
| Secondary | Test of Interpersonal Competence and Personal Vulnerability | Change in the 20-item multiple-choice interpersonal competence and vulnerability of individuals with ID. Each question has three answers with only one best answer for each question.Scoring is from 0 to 1 with 1 being the best answer. Scores range from 0 to 20 with higher scores showing improvement in interpersonal competence and personal vulnerability. | Pre, post (9 weeks), and 2 month follow-up | |
| Secondary | Social Vulnerability Questionnaire | Change in social vulnerability in individuals with ID as measured by 45 items that assess social vulnerability. Care provider rates individual with ID on a 4-point Likert scale (1=not true or never to 4= very true or always). Scores range from 45 to 180. Lower scores reflect improvements in social vulnerability. | Pre, post (9 weeks), and 2 month follow-up |