Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Protect Yourself: Abuse Prevention for People With Intellectual Disabilities (AP4ID)

13. februar 2023 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Oregon
      • Eugene, Oregon, Forenede Stater, 97405
        • Double S Instructional Systems

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.
Aktiv komparator: 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.
The control group will receive worksheets from the ESCAPE-NOW curriculum.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Abuse Protection Concept Questionnaire
Tidsramme: Pre, post (9 weeks), and 2 month follow-up
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
Tidsramme: Pre, post (9 weeks), and 2 month follow-up
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glascow Social Self-Efficacy Scale
Tidsramme: Pre, post (9 weeks), and 2 month follow-up
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
Test of Interpersonal Competence and Personal Vulnerability
Tidsramme: Pre, post (9 weeks), and 2 month follow-up
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
Social Vulnerability Questionnaire
Tidsramme: Pre, post (9 weeks), and 2 month follow-up
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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adults with ID Consumer Satisfaction
Tidsramme: Post (9 weeks)
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)
Learning Partner Consumer Satisfaction
Tidsramme: Post (9 weeks)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

4. oktober 2022

Primær færdiggørelse (Forventet)

30. november 2022

Studieafslutning (Forventet)

31. december 2022

Datoer for studieregistrering

Først indsendt

22. juni 2019

Først indsendt, der opfyldte QC-kriterier

24. juni 2019

Først opslået (Faktiske)

26. juni 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2023

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2023

Sidst verificeret

1. februar 2023

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AbusePhaseII
  • R44HD079119-02 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD-delingstidsramme

Data will be available within 6 months of study completion.

IPD-delingsadgangskriterier

Data access requests will be reviewed by an external independent reviewer. Requestors will be required to sign a data access agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Abuse Prevention

Kliniske forsøg med Abuse Prevention Program

3
Abonner