- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03998605
Protect Yourself: Abuse Prevention for People With Intellectual Disabilities (AP4ID)
13 februari 2023 uppdaterad av: 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.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Martin R Sheehan, Ph.D.
- Telefonnummer: 641-603-0304
- E-post: DocMartin817@yahoo.com
Studera Kontakt Backup
- Namn: Laura Jones, Ph.D
- Telefonnummer: 541-603-0304
- E-post: jonesl@linnbenton.edu
Studieorter
-
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Oregon
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Eugene, Oregon, Förenta staterna, 97405
- Double S Instructional Systems
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Kontakt:
- Laura Jones, Ph.D
- Telefonnummer: 541-603-0304
- E-post: jonesl@linnbenton.edu
-
Kontakt:
- Martin Sheehan, Ph.D
- Telefonnummer: 541-603-0304
- E-post: DocMartin817@yahoo.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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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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.
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The control group will receive worksheets from the ESCAPE-NOW curriculum.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Abuse Protection Concept Questionnaire
Tidsram: 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.
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Pre, post (9 weeks), and 2 month follow-up
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Abuse Protection Decision Making and Task Analysis Check Sheet
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Glascow Social Self-Efficacy Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Adults with ID Consumer Satisfaction
Tidsram: 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.
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Post (9 weeks)
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Learning Partner Consumer Satisfaction
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
4 oktober 2022
Primärt slutförande (Förväntat)
30 november 2022
Avslutad studie (Förväntat)
31 december 2022
Studieregistreringsdatum
Först inskickad
22 juni 2019
Först inskickad som uppfyllde QC-kriterierna
24 juni 2019
Första postat (Faktisk)
26 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 februari 2023
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 februari 2023
Senast verifierad
1 februari 2023
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AbusePhaseII
- R44HD079119-02 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Tidsram för IPD-delning
Data will be available within 6 months of study completion.
Kriterier för IPD Sharing Access
Data access requests will be reviewed by an external independent reviewer.
Requestors will be required to sign a data access agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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