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Parenting Matters: Helping Parents With Young Children

11 de abril de 2018 actualizado por: University of Western Ontario, Canada
Sleep and discipline problems are the most common problems for parents of young children (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child behavior problems. The Parenting Matters program combines treatment booklets and telephone support to help parents deal with sleep or discipline problems. Parents with concerns and who are interested in the study are identified during a visit to their family physician. We, the investigators at the University of Western Ontario, expect that parents receiving treatment booklets, along with usual care by their family physician, will have greater reductions in their child's sleep or discipline problems, improved parenting practices, and greater reductions in child behaviour problems after receiving the Parenting Matters intervention, compared to parents receiving usual medical care.

Descripción general del estudio

Descripción detallada

About 1 in 5 young children (ages 2 to 5 years) has a significant psychosocial problem, but over 80% do not receive treatment. Without treatment, up to half of these children will have problems into childhood and adolescence. New methods of treating and preventing children's psychosocial problems are needed.

Sleep and discipline problems (or child non-compliance) are the most common problems for parents of young children, and are the two concerns with the strongest relations to future child behavior problems. Further, parenting practices have consistently been linked to the development of psychosocial problems. The Parenting Matters program combines treatment booklets and telephone support to help parents with sleep or discipline problems among young children.

Objectives:

  • Test the efficacy of the Parenting Matters program interventions for sleeping and bedtime behaviors (Trial 1), and discipline (Trial 2) in reducing problem-specific outcomes.
  • Test the effects of the Parenting Matters program interventions for parents who are concerned about both their children's sleep and discipline (Trial 3) in reducing problem-specific outcomes related to sleep (Group 1) and discipline problems (Group 2) will be tested.
  • Test the efficacy of the Parenting Matters program in improving parenting practices.
  • Test the efficacy of the Parenting Matters program in reducing child behaviour problems in general.
  • Examine predictors of treatment success.

Method:

All parents of 2 to 5 year-olds seen in a family practice for a routine appointment are asked to complete a psychosocial concerns checklist. Parents who have concerns regarding their child's sleep (Trial 1), how to discipline their child (Trial 2), or concerns about both their child's sleep and discipline (Trial 3), and meet the other study criteria, are invited to take part in the study. Mailed baseline assessment packages assess children's behavior, parenting practices and potential predictors of treatment success.

Parents are randomized to usual care, or the Parenting Matters program along with usual care. The Parenting Matters program includes treatment booklets addressing either sleep or discipline problems, and telephone coach support (3 calls over 6 weeks).

Primary outcomes are parents' ratings of their children's sleep or discipline problems measured at post-treatment (7 weeks after baseline). Parents repeat assessment packages at 3- and 6-month follow-ups.

Goals & Relevance:

This research addresses the need for new ways of providing early interventions for young children that:

  • reach the largest number of individuals in need;
  • are cost effective; and
  • time efficient.

By addressing the most common issues facing parents of young children, it engages parents in areas of direct relevance to them. The program focuses on parenting practices thereby building family strengths that may have a lasting impact on child development. Collaboration with family physicians builds on the ongoing positive relationships between parents and family physicians and provides a mechanism to reach a significant proportion of young children.

Tipo de estudio

Intervencionista

Inscripción (Actual)

548

Fase

  • Fase 2

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.

Ubicaciones de estudio

    • Ontario
      • London, Ontario, Canadá, N6C 5A2
        • University of Western Ontario

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

16 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Parent (primary caregiver) of a 2-5 year old child
  • Attending a medical appointment at a family medical practice
  • Phone in home
  • Parent concerned about child's sleep and/or discipline
  • Parent interested in participating in a treatment study

Exclusion Criteria:

  • Parent non-English speaking
  • Child with significant physical or developmental disability
  • Parent's only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting
  • No phone

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Cuidado usual
Parents in the usual care condition were told to continue with care from their family physician and/or any other treatment recommended by the physician.
Experimental: Treatment booklet and telephone coaching
The Parenting Matters treatment program consisted of a self-help treatment booklet and two telephone coaching calls from a paraprofessional telephone coach at Weeks 2 and 5 of the program. Two booklets were used in the three trials; one addressed sleep issues and the second discipline problems.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Sleep and bedtime problems trial (Trial 1): parent report on the Children's Sleep Habits Questionnaire
Periodo de tiempo: 7 weeks post randomization
7 weeks post randomization
Discipline problems trial (Trial 2): parent rated total problem score on the Eyberg Child Behavior Inventory
Periodo de tiempo: 7 weeks post randomization
7 weeks post randomization
Sleep and discipline problems trial (Trial 3): parent report on the Children's Sleep Habit Questionnaire (Group 1-sleep treatment) and parent rated total problem score on the Eyberg Child Behavior Inventory (Group 2-discipline treatment)
Periodo de tiempo: 7 weeks post randomization
7 weeks post randomization

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Parenting practices-total score on the Parenting Scale
Periodo de tiempo: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
General child behavior problems-total problem score on the Child Behavior Checklist
Periodo de tiempo: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Daily recall ratings of sleep and discipline problems (3 reports in total)
Periodo de tiempo: 4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Parent report on the Richman sleep questionnaires (only for Trial 1-sleep and bedtime problems and for Trial 3 participants if in sleep treatment condition)
Periodo de tiempo: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Graham J Reid, PhD, Western University, Canada

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

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 julio de 2005

Finalización primaria (Actual)

1 de marzo de 2009

Finalización del estudio (Actual)

1 de marzo de 2009

Fechas de registro del estudio

Enviado por primera vez

18 de agosto de 2005

Primero enviado que cumplió con los criterios de control de calidad

18 de agosto de 2005

Publicado por primera vez (Estimar)

22 de agosto de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de abril de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

11 de abril de 2018

Última verificación

1 de agosto de 2011

Más información

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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