- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03998605
Protect Yourself: Abuse Prevention for People With Intellectual Disabilities (AP4ID)
13 de febrero de 2023 actualizado por: 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.
Descripción general del estudio
Estado
Retirado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Martin R Sheehan, Ph.D.
- Número de teléfono: 641-603-0304
- Correo electrónico: DocMartin817@yahoo.com
Copia de seguridad de contactos de estudio
- Nombre: Laura Jones, Ph.D
- Número de teléfono: 541-603-0304
- Correo electrónico: jonesl@linnbenton.edu
Ubicaciones de estudio
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Oregon
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Eugene, Oregon, Estados Unidos, 97405
- Double S Instructional Systems
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Contacto:
- Laura Jones, Ph.D
- Número de teléfono: 541-603-0304
- Correo electrónico: jonesl@linnbenton.edu
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Contacto:
- Martin Sheehan, Ph.D
- Número de teléfono: 541-603-0304
- Correo electrónico: DocMartin817@yahoo.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Abuse Protection Concept Questionnaire
Periodo de tiempo: Pre, post (9 weeks), and 2 month follow-up
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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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Pre, post (9 weeks), and 2 month follow-up
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Abuse Protection Decision Making and Task Analysis Check Sheet
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Glascow Social Self-Efficacy Scale
Periodo de tiempo: 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.
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Pre, post (9 weeks), and 2 month follow-up
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Test of Interpersonal Competence and Personal Vulnerability
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Adults with ID Consumer Satisfaction
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
4 de octubre de 2022
Finalización primaria (Anticipado)
30 de noviembre de 2022
Finalización del estudio (Anticipado)
31 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
22 de junio de 2019
Primero enviado que cumplió con los criterios de control de calidad
24 de junio de 2019
Publicado por primera vez (Actual)
26 de junio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de febrero de 2023
Última actualización enviada que cumplió con los criterios de control de calidad
13 de febrero de 2023
Última verificación
1 de febrero de 2023
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AbusePhaseII
- R44HD079119-02 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Marco de tiempo para compartir IPD
Data will be available within 6 months of study completion.
Criterios de acceso compartido de IPD
Data access requests will be reviewed by an external independent reviewer.
Requestors will be required to sign a data access agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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