Clinical trial NCT02697110: Family Inclusive Early Brain Stimulation
Official title: Family Inclusive Early Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Stimulation
Keywords: Cognition
Brain Stimulation
Early Child Development
Lead sponsor: University of Ibadan
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
First posted: 2016-03-03
Enrollment: 480
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
timeFrame: 6weeks, 14 weeks, 9months, 12 months and 18 months
measure: Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire
timeFrame: 18 months
measure: Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards
timeFrame: 6weeks to 18 months
Secondary outcomes:
measure: Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument
timeFrame: 9mths -12 months
measure: Mothers engagement of fathers and other caregivers on early brain stimulation as measured by simple questionnaire on mothers self-reported father engagement activity
timeFrame: 6-18months
measure: 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
timeFrame: 18 months
measure: Increased knowledge and competence of health workers on early brain stimulation as measured by study derived composite questionnaire on knowledge and competence on intervention
timeFrame: 14weeks - 9months
Other outcomes:
Locations:
Study officials:
affiliation: College of Medicine University of Ibadan
name: Akindele O Adebiyi, MBchB, MPH
role: PRINCIPAL_INVESTIGATOR
References: