An interventional study of Edutainment based intervention in Brain Stimulation, sponsored by University of Ibadan. Completed. Open to participants aged 1 Week to 6 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-06.
Sponsored by University of Ibadan · Not applicable, Interventional, and Other
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.
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.
University of Ibadan is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Edutainment based intervention
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.
Edutainment intervention package
Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
Reduced socio-cognitive deficit in the intervention compared to the control group at 18 months of age
Time frame: 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
Improved child stimulation practices in the intervention compared to the control group at 18 months of age
Time frame: 18 months
Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards
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
Time frame: 6weeks to 18 months
Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument
An increase in mothers knowledge and competence on child brain stimulation practices
Time frame: 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
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.
Time frame: 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
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)
Time frame: 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
The competence and knowledge of health workers to successfully deliver intervention this intervention after being trained would also be a secondary measure of success.
Time frame: 14weeks - 9months
No study locations are listed for this record.
Plan to share: Undecided — Decision would be based on research teams final decision after the crucial manuscripts have been published
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University of Ibadan