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Family Inclusive Early Brain Stimulation

Family Inclusive Early Brain Stimulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02697110
Acronym
FINEBRAINS
Enrollment
480
Registered
2016-03-03
Start date
2014-11-30
Completion date
2016-08-31
Last updated
2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Stimulation

Keywords

Cognition, Brain Stimulation, Early Child Development

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALEdutainment based intervention

Edutainment intervention package

Sponsors

Grand Challenges Canada
CollaboratorOTHER
University of Ibadan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 6 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)6weeks, 14 weeks, 9months, 12 months and 18 monthsReduced socio-cognitive deficit in the intervention compared to the control group at 18 months of age
Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire18 monthsImproved child stimulation practices in the intervention compared to the control group at 18 months of age
Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards6weeks to 18 monthsAppropriate 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

Secondary

MeasureTime frameDescription
Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument9mths -12 monthsAn increase in mothers knowledge and competence on child brain stimulation practices
Increased knowledge and competence of health workers on early brain stimulation as measured by study derived composite questionnaire on knowledge and competence on intervention14weeks - 9monthsThe competence and knowledge of health workers to successfully deliver intervention this intervention after being trained would also be a secondary measure of success.
Mothers engagement of fathers and other caregivers on early brain stimulation as measured by simple questionnaire on mothers self-reported father engagement activity6-18monthsMothers 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.
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 Tool18 monthsfathers' 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026