- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07303062
Programa de Crianza para la Salud Mental Adolescente para el Fortalecimiento de la Relación Niño-Adulto (AMP-CARE)
Evaluación del Impacto del Programa de Salud Mental para Adolescentes AMP-CARE para el Mejoramiento de la Relación Niño-Adulto
The purpose of this research study is to learn if a parenting program called Adolescent Mental Health Parenting Program for Child Adult Relationship Enhancement (AMP-CARE) can help parents have more confidence in parenting their teen and improve their knowledge about normal teen development and teen mental health. The main questions it aims to answer are:
- Does the AMP-CARE parenting program improve confidence in teen parenting and positive parenting?
- Does the AMP-CARE parenting program improve parent knowledge about mental health?
Researchers will compare participants who complete the parenting program to those who do not.
Participants will:
- Complete 2 surveys, one at the start of the study and one 6 -12 weeks later
- Half of the participants will be randomly picked to attend the 6 virtual AMP-CARE sessions right away.
- The other half will have the opportunity to attend AMP-CARE after they complete the second survey.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this randomized controlled trial, 60 parents of teens, ages 11-14 years, will be randomized to either AMP-CARE or wait-list control to achieve the following aims:
AIM 1. To measure the impact of AMP-CARE on parent mental health literacy as measured by the Parental Child Mental Health Literacy Questionnaire (PCMHLQ).
AIM 2: To measure the impact of AMP-CARE on parenting self-efficacy as measured by the Parenting Self Efficacy Scale.
AIM 3: To measure the impact of AMP-CARE on promotive parenting practices assessed by the Positive Parenting and Parental Involvement subscales of the Alabama Parenting Questionnaire.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
-
Cary, North Carolina, Estados Unidos, 27519
- Reclutamiento
- UNC Pediatrics at Panther Creek
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Contacto:
- Priyanka Rao, MD
- Número de teléfono: (919) 481-4997
- Correo electrónico: priyanka_rao@med.unc.edu
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Chapel Hill, North Carolina, Estados Unidos, 27517
- Reclutamiento
- UNC Children's Primary and Specialty Care at Carolina Pointe II
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Investigador principal:
- Yasamin Sanii, MD
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Sub-Investigador:
- Samantha Schilling, MD, MSPH
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Contacto:
- Katherine Jordan, MD
- Número de teléfono: (984) 974-6669
- Correo electrónico: katherine_jordan@med.unc.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Parent or guardian of teen age 11-14 years
- Receiving primary care at selected study sites
- English speaking
Exclusion Criteria:
- Parents of children with severe mental illness (indicated by psychiatric hospitalization in the last 12 months or previous diagnosis of psychosis)
- Parents of children with severe developmental delay (indicated by prior diagnosis of severe neurodevelopmental impairment, global developmental delay, severe expressive language delay)
- Not available at time group is scheduled
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: AMP-CARE
Parents will attend the 6 virtual sessions with a group of about 5-10 parents and 2 facilitators. The AMP-CARE group sessions are held for about 90 minutes once per week. Sessions include didactics, role playing, vignettes, and weekly home practice to build positive parenting techniques. |
The goals of AMP-CARE are to teach parents how to form a positive relationship with their teen and to teach about typical adolescent development and mental health. Each AMP-CARE session will be led by 1 or 2 trainers. About 4 to 13 parents will attend each virtual session lasting approximately 1.5 hours. Sessions will be weekly for 6 weeks. Participants are encouraged to practice the skills learned at AMP-CARE between the sessions. |
|
Sin intervención: Waitlist Control
Parents in the control group will be offered the intervention after completing the second study questionnaire. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parent Mental Health Literacy
Periodo de tiempo: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Parent Mental Health Literacy was assessed with 23-item self-report measure, the Parental Child Mental Health Literacy Questionnaire. Using a 5-pt scale with endpoints of "0=strongly disagree" and "4=strongly agree," parents were asked to indicate their level of agreement with statements related to 5 constructs: mental health recognition, beliefs, knowledge, help-seeking confidence, and fear of stigma. Scores ranged from 0 to 4. Higher scores indicate greater literacy. |
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parent Self Efficacy
Periodo de tiempo: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Parenting self-efficacy was assessed with the 19-item self-report measure Parenting Self Efficacy Scale. Using a 5-point scale, parents indicated how frequently states related to their efficacy to develop positive teenager behavior, their efficacy to respond competently to negative teenager behavior, and their monitoring efficacy were true from "1=never" to 5 "always." Total scores ranged from 1 to 5 with higher scores indicating greater self-efficacy. |
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
|
Promotive Parenting Practices
Periodo de tiempo: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Promotive parenting practices were assessed with 16 self-report items from two subscales of Alabama Parenting Questionnaire. The positive involvement subscale includes 10 items, with a range of possible scores from 10 to 50. The positive parenting subscale includes 6 items, with a range of possible scores from 6 to 30. Parents rate the frequency with which each parenting practice occurs in their home from "1=never" to "5=always." Higher scores indicate more positive parenting. |
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Samantha Schilling, MD MSHP, University of North Carolina, Chapel Hill
- Investigador principal: Yasamin Sanii, MD, University of North Carolina, Chapel Hill
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20-3652
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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