- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01829815
Impact of a Parenting Program in Liberia to Improve Parenting, Education, and Health Outcomes for Children in Liberia
22 janvier 2016 mis à jour par: International Rescue Committee
Impact Evaluation of a Parenting Program to Improve Parenting, Education, and Health Outcomes for Young Children in Liberia
The aim of this study is to assess the impact of an intervention to improve parenting practices, pre-academic and developmental skills, and use of mosquito nets for children in kindergarten in Liberia.
A rigorous impact evaluation using a randomized, waitlist controlled design will be conducted to measure the impact of the intervention on three primary outcomes: positive parenting skills, children's cognitive and educational skills, and malaria knowledge and prevention behaviors.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
270
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Lofa County
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Voinjama, Lofa County, Libéria
- International Rescue Committee
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Parents or primary caregivers (age 18 or above) of children ages 3-7 enrolled in kindergarten
- Resident in one of five study sites
Exclusion Criteria:
- Severe cognitive disability of caregiver affecting ability to provide informed consent
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: "Parents Make the Difference"
Caregivers are enrolled in the 10-session Parents Make the Difference intervention.
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The intervention, entitled "Parents Make the Difference," will include 10 sessions.
Parents will attend in a group, and sessions will include didactic information, guided discussion, and modeling and practice of new skills.
All sessions focus on positive parenting skills, with specific skills across three domains that have strong links to child outcomes: (a) positive, non-physical behavior management strategies, (b) strategies for promoting children's early learning, and (c) strategies, primarily use of bed nets, for preventing malaria in children.
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Autre: Waitlist Control
Caregivers assigned to the control group received the 10-session Parents Make the Difference intervention after the study was completed.
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The intervention, entitled "Parents Make the Difference," will include 10 sessions.
Parents will attend in a group, and sessions will include didactic information, guided discussion, and modeling and practice of new skills.
All sessions focus on positive parenting skills, with specific skills across three domains that have strong links to child outcomes: (a) positive, non-physical behavior management strategies, (b) strategies for promoting children's early learning, and (c) strategies, primarily use of bed nets, for preventing malaria in children.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Parenting Behavior Assessment (adapted from multiple scales for this context)
Délai: 1 month
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This is a caregiver-report survey measures including items on various parenting practices, including: caregiver-child communication; discipline and behavior management practices; caregiver-child affection and shared activities; caregiver involvement in child's school and educational activities.
These items will yield several subscores for these different domains.
Some items may also be analyzed as single items, as they measure specific and important outcomes (e.g., use of a harsh discipline strategy)
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1 month
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Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context)
Délai: 1 month
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These items assess parents' confidence in their parenting abilities and their beliefs about caregiving practices.
This measure will yield separate scores for self-efficacy and beliefs about caregiving practices.
Some items may also be analyzed as single items, as they measure specific and important outcomes (e.g., parents' belief about an aspect of harsh discipline)
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1 month
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Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire)
Délai: 1 month
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This tool assess children's behaviors and emotional well-being in the domains of hyperactivity, anger, aggression, mood, and peer relationships.
They will be analyzed as an overall score, and single items may be analyzed for certain behaviors or indicators of emotional well-being.
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1 month
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Parent-Child Interaction Observation
Délai: 1 month
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Caregivers and children in the study will be asked to engage in a play interaction for five minutes, and their verbal interactions will be audio-recorded.
Recordings will be coded for specific behaviors.
The coding system is adapted from the Dyadic Parent Child Interaction Coding System.
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1 month
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Child Cognitive / Pre-Academic Abilities and Emotional Well-being
Délai: 1 month
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Children will be administered activity-based items to assess a range of cognitive and learning skills, including verbal and language skills (as measured by several activities), numeracy, and pattern recognition.
Items will be combined into composite scores but may also be analyzed separately to measure outcomes on specific abilities (e.g., counting).
Children will also be asked five questions related to their emotional well-being adapted from the Strengths and Difficulties Questionnaire.
These items will be analyzed as a sum score, and individual items may be analyzed for specific indicators of emotional well-being.
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1 month
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mosquito net usage
Délai: 1 month
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A survey will be used to assess mosquito net usage by household members.
Items will be analyzed separately to assess discrete behaviors (e.g., whether child him/herself slept under the net; whether any adult(s) slept under the net)
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1 month
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Eve Puffer, PhD, Duke University
- Chercheur principal: Rhea Chase, PhD, Duke University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Annan J, Sim A, Puffer ES, Salhi C, Betancourt TS. Improving Mental Health Outcomes of Burmese Migrant and Displaced Children in Thailand: a Community-Based Randomized Controlled Trial of a Parenting and Family Skills Intervention. Prev Sci. 2017 Oct;18(7):793-803. doi: 10.1007/s11121-016-0728-2.
- Puffer ES, Green EP, Chase RM, Sim AL, Zayzay J, Friis E, Garcia-Rolland E, Boone L. Parents make the difference: a randomized-controlled trial of a parenting intervention in Liberia. Glob Ment Health (Camb). 2015 Aug 4;2:e15. doi: 10.1017/gmh.2015.12. eCollection 2015.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2012
Achèvement primaire (Réel)
1 mars 2013
Achèvement de l'étude (Réel)
1 mars 2013
Dates d'inscription aux études
Première soumission
8 avril 2013
Première soumission répondant aux critères de contrôle qualité
8 avril 2013
Première publication (Estimation)
11 avril 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
25 janvier 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 janvier 2016
Dernière vérification
1 janvier 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5108
Plan pour les données individuelles des participants (IPD)
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