- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00133055
Parenting Matters: Helping Parents With Young Children
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Ontario
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London, Ontario, Canada, N6C 5A2
- University of Western Ontario
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: Soins habituels
|
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.
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Sleep and bedtime problems trial (Trial 1): parent report on the Children's Sleep Habits Questionnaire
Délai: 7 weeks post randomization
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7 weeks post randomization
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Discipline problems trial (Trial 2): parent rated total problem score on the Eyberg Child Behavior Inventory
Délai: 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)
Délai: 7 weeks post randomization
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7 weeks post randomization
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Parenting practices-total score on the Parenting Scale
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Graham J Reid, PhD, Western University, Canada
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 67816; 280205-014
- ISRCTN81511074
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