Family Inclusive Early Brain Stimulation (FINEBRAINS)
4. Februar 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
480
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
1 Woche bis 1 Monat (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
|
Kein Eingriff: B
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
Zeitfenster: 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
|
6weeks, 14 weeks, 9months, 12 months and 18 months
|
|
Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire
Zeitfenster: 18 months
|
Improved child stimulation practices in the intervention compared to the control group at 18 months of age
|
18 months
|
|
Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards
Zeitfenster: 6weeks to 18 months
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument
Zeitfenster: 9mths -12 months
|
An increase in mothers knowledge and competence on child brain stimulation practices
|
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
Zeitfenster: 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.
|
6-18months
|
|
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
Zeitfenster: 18 months
|
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)
|
18 months
|
|
Increased knowledge and competence of health workers on early brain stimulation as measured by study derived composite questionnaire on knowledge and competence on intervention
Zeitfenster: 14weeks - 9months
|
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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Akindele O Adebiyi, MBchB, MPH, College of Medicine, University of Ibadan
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2014
Primärer Abschluss (Tatsächlich)
1. August 2016
Studienabschluss (Tatsächlich)
1. August 2016
Studienanmeldedaten
Zuerst eingereicht
22. Februar 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
25. Februar 2016
Zuerst gepostet (Schätzen)
3. März 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. Februar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Februar 2019
Zuletzt verifiziert
1. Februar 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- AD/13/479/741
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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