- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01829815
Impact of a Parenting Program in Liberia to Improve Parenting, Education, and Health Outcomes for Children in Liberia
22. januar 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
270
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Lofa County
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Voinjama, Lofa County, Liberia
- International Rescue Committee
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: "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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Andet: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Parenting Behavior Assessment (adapted from multiple scales for this context)
Tidsramme: 1 month
|
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)
Tidsramme: 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)
Tidsramme: 1 month
|
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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mosquito net usage
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Eve Puffer, PhD, Duke University
- Ledende efterforsker: Rhea Chase, PhD, Duke University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2012
Primær færdiggørelse (Faktiske)
1. marts 2013
Studieafslutning (Faktiske)
1. marts 2013
Datoer for studieregistrering
Først indsendt
8. april 2013
Først indsendt, der opfyldte QC-kriterier
8. april 2013
Først opslået (Skøn)
11. april 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. januar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5108
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