Protect Yourself: Abuse Prevention for People With Intellectual Disabilities (AP4ID)
2023년 2월 13일 업데이트: Double S Instructonal Systems
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.
연구 개요
상세 설명
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.
연구 유형
중재적
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Oregon
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Eugene, Oregon, 미국, 97405
- Double S Instructional Systems
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Abuse Prevention Program Condition
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.
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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.
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활성 비교기: Control condition
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.
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The control group will receive worksheets from the ESCAPE-NOW curriculum.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Abuse Protection Concept Questionnaire
기간: 사전, 사후(9주) 및 2개월 추적
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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.
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사전, 사후(9주) 및 2개월 추적
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Abuse Protection Decision Making and Task Analysis Check Sheet
기간: Pre, post (9 weeks), and 2 month follow-up
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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.
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Pre, post (9 weeks), and 2 month follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Glascow Social Self-Efficacy Scale
기간: Pre, post (9 weeks), and 2 month follow-up
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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.
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Pre, post (9 weeks), and 2 month follow-up
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Test of Interpersonal Competence and Personal Vulnerability
기간: Pre, post (9 weeks), and 2 month follow-up
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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.
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Pre, post (9 weeks), and 2 month follow-up
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Social Vulnerability Questionnaire
기간: Pre, post (9 weeks), and 2 month follow-up
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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.
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Pre, post (9 weeks), and 2 month follow-up
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adults with ID Consumer Satisfaction
기간: Post (9 weeks)
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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.
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Post (9 weeks)
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Learning Partner Consumer Satisfaction
기간: Post (9 weeks)
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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.
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Post (9 weeks)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2022년 10월 4일
기본 완료 (예상)
2022년 11월 30일
연구 완료 (예상)
2022년 12월 31일
연구 등록 날짜
최초 제출
2019년 6월 22일
QC 기준을 충족하는 최초 제출
2019년 6월 24일
처음 게시됨 (실제)
2019년 6월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2023년 2월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2023년 2월 13일
마지막으로 확인됨
2023년 2월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- AbusePhaseII
- R44HD079119-02 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD 공유 기간
Data will be available within 6 months of study completion.
IPD 공유 액세스 기준
Data access requests will be reviewed by an external independent reviewer.
Requestors will be required to sign a data access agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Abuse Prevention에 대한 임상 시험
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Near East University, TurkeyAl-Ahli Hospital, Hebron모집하지 않고 적극적으로DVT 예방 | DVT - 심부 정맥 혈전증 | 심장 온펌프 수술 | DVT 예방 | On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications | 간호 관리 프로토콜키프로스
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AdventHealthState of Florida Department of Health모병
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Peking University모집하지 않고 적극적으로
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University of Texas Southwestern Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD)초대로 등록