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Clinical Trials/NCT02697110
NCT02697110
Completed
Not Applicable

Family Inclusive Early Brain Stimulation

University of Ibadan0 sites480 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Stimulation
Sponsor
University of Ibadan
Enrollment
480
Primary Endpoint
Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
August 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. A.O. Adebiyi

Coordinator, College of Medicine Research and innovation Management Unit

University of Ibadan

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

Outcomes

Primary Outcomes

Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)

Time Frame: 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

Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire

Time Frame: 18 months

Improved 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 Standards

Time Frame: 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

Secondary Outcomes

  • Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument(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(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(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(14weeks - 9months)

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