Family Inclusive Early Brain Stimulation (FINEBRAINS)
4 februari 2019 bijgewerkt door: Dr. A.O. Adebiyi, University of Ibadan
Social interaction (in the form of serve and return exchanges) between child and parent are crucial for psychosocial, physical and cognitive development.
Parents in sub-Saharan countries are ill-equipped to maximize the benefits from this interaction.
The investigators approach builds on the traditional outlook that "it takes a village to raise a child" i.e., not only the parents but other extended family members play a role as caregivers to young children.
The investigators intention is to use the existing post-natal/child welfare clinics to deliver an intervention, which uses culturally acceptable videos and active skills building, to deliver health messages and practical skills to women, with the intention that they will subsequently engage and teach their partners and other caregivers about early brain stimulation and child development.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
A two arm cluster randomized control design will be used to select a total of about 400 participants each of the control and intervention groups. The participants will be drawn from primary health care (PHC) centres offering immunization services in Ibadan. In the intervention group, mothers will be trained on early brain stimulation using group video sessions followed by individualised question and answer sessions. These sessions will take place at 6 week and 10 week post natal immunisation visits. The control arm will receive the standard of care - routine immunization care- group health talks.
The child's development will be assessed using the Survey of Wellbeing of Young Children (SWYC) instrument.
Outcome variables will include changes in self-reported early child brain stimulation behaviour and increase in the awareness of parents and significant others on the social and emotional difficulties of children.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
480
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
1 week tot 1 maand (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- All mothers with live children aged 1-6 weeks
Exclusion Criteria:
- Mothers of children with moderate to severe birth asphyxia or gross congenital anomalies
- Mothers who are unable to communicate to provide information
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: A: Edutainment based intervention
This group receives the usual routine immunization at 6, 10, 14 weeks and 9 months and an Edutainment intervention package of limited group (i.e., 3-5 women) drama based video session (Edutainment) followed by a Question and Answer session with mothers on early brain development, parenting skills, communication and negotiating skills at 6 weeks.
Mothers will be encouraged to train fathers and other caregivers at home with reinforcement of key messages at subsequent clinic visits.
Key messages will be delivered through the use of flip charts at 14 weeks and given to mothers as take home for use in engaging the fathers partners and other caregivers for their child.
Reinforcement of key messages at subsequent visits will be through the use of videos and flip chart.
|
Edutainment intervention package
|
|
Geen tussenkomst: B
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
Tijdsspanne: 6weeks, 14 weeks, 9months, 12 months and 18 months
|
Reduced socio-cognitive deficit in the intervention compared to the control group at 18 months of age
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6weeks, 14 weeks, 9months, 12 months and 18 months
|
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Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire
Tijdsspanne: 18 months
|
Improved child stimulation practices in the intervention compared to the control group at 18 months of age
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18 months
|
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Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards
Tijdsspanne: 6weeks to 18 months
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Appropriate for Age physical development of children such as Head circumference, Length/height, Weight for Age as measured by The WHO head circumference growth curves and WHO Child Growth Standards
|
6weeks to 18 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument
Tijdsspanne: 9mths -12 months
|
An increase in mothers knowledge and competence on child brain stimulation practices
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9mths -12 months
|
|
Mothers engagement of fathers and other caregivers on early brain stimulation as measured by simple questionnaire on mothers self-reported father engagement activity
Tijdsspanne: 6-18months
|
Mothers are expected to effectively engage their male partners and other caregivers on child development.
This will be demonstrated by their success at getting their male partner and other caregivers trained at home.
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6-18months
|
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fathers' self- reported engagement and investment in the early childhood development as measured by study derived adaptations of the "Self-Perceptions of the Parental Role scale (SPPR)" and the Early Childhood Study Survey Tool
Tijdsspanne: 18 months
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fathers' self- reported engagement and investment in the early childhood development would improve (responsible behaviour, emotional engagement, physical accessibility, material support, involvement in child care, influence in child rearing decisions)
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18 months
|
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Increased knowledge and competence of health workers on early brain stimulation as measured by study derived composite questionnaire on knowledge and competence on intervention
Tijdsspanne: 14weeks - 9months
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The competence and knowledge of health workers to successfully deliver intervention this intervention after being trained would also be a secondary measure of success.
|
14weeks - 9months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Akindele O Adebiyi, MBchB, MPH, College of Medicine, University of Ibadan
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2014
Primaire voltooiing (Werkelijk)
1 augustus 2016
Studie voltooiing (Werkelijk)
1 augustus 2016
Studieregistratiedata
Eerst ingediend
22 februari 2016
Eerst ingediend dat voldeed aan de QC-criteria
25 februari 2016
Eerst geplaatst (Schatting)
3 maart 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 februari 2019
Laatste update ingediend die voldeed aan QC-criteria
4 februari 2019
Laatst geverifieerd
1 februari 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- AD/13/479/741
Plan Individuele Deelnemersgegevens (IPD)
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ONBESLIST
Beschrijving IPD-plan
Decision would be based on research teams final decision after the crucial manuscripts have been published
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