- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02330666
Parent-child Communication and Health-risk Behavior (MP)
30 de septiembre de 2015 actualizado por: University of Wisconsin, Madison
Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for health problems that may compromise their futures and are extremely costly to society.
Positive parent-child communication, characterized by openness, satisfaction with the family, caring, and effective problem-solving, has been found to be protective against a youth's involvement in health-risk behaviors.
To promote positive adult-youth communication, in earlier work we developed, tested, and found efficacious an intervention, Mission Possible: Parents and Kids Who Listen (MP).
This study is designed to test the following hypotheses: (a) Adults and youth who participate in MP will demonstrate more positive communication when compared with adults who did not participate; (b) Youth who participate in MP will have a lower incidence of health-risk behavior when compared with youth who did not participate; and (c) Positive adult-youth communication will mediate childhood health-risk behavior in the presence of risk processes that predict participation.
The experimental design is a 2-group (intervention and comparison) pre-test repeated measures design with six waves of data collection over three years and two booster sessions of the intervention.
Elementary school and community centers in Madison and Chicago served as recruitment sites for parent-child dyads.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
604
Fase
- No aplica
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
10 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adults and youth must be English speakers
- Youth must be 10 years old
Exclusion Criteria:
- Severe mental or physical illness that could preclude involvement in data collection procedures
- Family plans to move from the metropolitan areas prior to study completion
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 |
|---|---|
|
Sin intervención: Comparison
Standard care
|
|
|
Experimental: Intervention
Communication skills training Mission Possible: Parents & Kids Who Listen
|
MP is a 12-hour, 6-session, manualized skills training program with 2 boosters.
Behavioral strategies teach adults and youth to communicate with one another emphasizing youth's need for flexible family boundaries, emotional closeness, and adults as resources.
Dyads attend together.
Sessions begin with relaxation exercises, review of the prior week's lessons and homework, and examination of success and failure in trying communication techniques.
New concepts are introduced using didactic videotaped presentations.
Lively, interactive, developmentally appropriate group exercises follow reflective of ethnic diversity that are reinforced with handouts and encouragement to try them at home.
Week-by-week content covers: Developmental Changes; Self-Esteem; Communicating What You Want; Listening to What the Other Wants; Solving Conflicts; and Letting Go.
The booster sessions are 2 hours in length and update developmental concepts; 5 basic listening skills; and 6 conflict resolution steps.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Youth Health Risk Behavior
Periodo de tiempo: 3 years
|
Measured with the 22-item Children's Health Risk Behavior Scale (CHRBS).
This instrument, based on the conceptual categories of the Youth Risk Behavioral Surveillance Survey, assesses potential for unintentional and intentional injury or violence, tobacco use, alcohol and other drug use, sexual curiosity, and health practices.
|
3 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Openness of Communication
Periodo de tiempo: 3 years
|
The Parent Adolescent Communication Inventory (Olson, 1983) is a 20-item, 2-subscale (open or problem communication) self-report instrument with a youth version and an adult version, the difference being the target of the item - mother/father or youth.
Scores are computed for adult communication, youth-mother communication, youth-father communication.
|
3 years
|
|
Family Satisfaction
Periodo de tiempo: 3 years
|
The Family Adaptability and Cohesion Evaluation Scale III is a 20-item, self-report instrument (Olson, 1994) to measure family satisfaction.
Participants answer the items twice, first to assess current and then to assess ideal family system conditions.
The difference between ideal and perceived conditions yields a family satisfaction score.
|
3 years
|
|
Problem-Solving Skill
Periodo de tiempo: 3 years
|
50% of the dyads were randomly selected for assessment of problem solving ability.
The procedure was to (a) identify a problem for discussion from the Issues Checklist (IC), (b) videotape the dyad attempting to solve the problem identified, and (c) code the videotaped interaction using the Iowa Family Interaction Rating Scales (IFIRS).
The IFIRS is a macro-level observational coding system that was initially developed in 1989 and has undergone 5 revisions.
Scales used to assess three aspects of family interaction were: (a) individual behavioral characteristics or each person's generalized interaction consisting of 8 items, e.g., use of humor, mood, whining and complaining; (b) dyadic behavioral characteristics or the nature of behavior exchanged from one family member to another consisting of 22 items, e.g., hostility, warmth/support; and (c) the family problem-solving process consisting of 10 items, e.g., solution quality, family enjoyment.
|
3 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Susan K Riesch, PhD, University of Wisconsin, Madison
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
1 de agosto de 2004
Finalización primaria (Actual)
1 de febrero de 2010
Finalización del estudio (Actual)
1 de diciembre de 2010
Fechas de registro del estudio
Enviado por primera vez
30 de diciembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
31 de diciembre de 2014
Publicado por primera vez (Estimar)
5 de enero de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de octubre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
30 de septiembre de 2015
Última verificación
1 de septiembre de 2015
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2003-352
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. .