Overview

This trial is active, not recruiting.

Condition brain stimulation
Treatment edutainment based intervention
Sponsor University of Ibadan
Collaborator Grand Challenges Canada
Start date November 2014
End date August 2016
Trial size 480 participants
Trial identifier NCT02697110, AD/13/479/741

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Arm
(Experimental)
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 based intervention
Edutainment intervention package
(No Intervention)
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.

Primary Outcomes

Measure
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
Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire
time frame: 18 months
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

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
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
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
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
time frame: 14weeks - 9months

Eligibility Criteria

Male or female participants up to 6 weeks old.

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

Additional Information

Official title Family Inclusive Early Brain Stimulation
Principal investigator Akindele O Adebiyi, MBchB, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Ibadan.