- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00133055
Parenting Matters: Helping Parents With Young Children
Descripción general del estudio
Estado
Intervención / Tratamiento
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
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá, N6C 5A2
- University of Western Ontario
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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 (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
¿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
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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.
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¿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
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7 weeks post randomization
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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
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7 weeks post randomization
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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
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7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
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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
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7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
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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
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4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
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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
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7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Graham J Reid, PhD, Western University, Canada
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- 67816; 280205-014
- ISRCTN81511074
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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