Family Inclusive Early Brain Stimulation

NCT02697110 | Completed DMC

• 1 other identifier: AD/13/479/741
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Stimulation

Keywords

Cognition; Brain Stimulation; Early Child Development

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  6weeks to 18 months

Secondary Outcomes (4)

• 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

Study Arms (2)

A: Edutainment based intervention

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.

Behavioral: Edutainment based intervention

B

NO INTERVENTION

This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.

Interventions

Edutainment based intervention BEHAVIORAL

Edutainment intervention package

A: Edutainment based intervention

Eligibility Criteria

• Age: 1 Week - 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All mothers with live children aged 1-6 weeks

You may not qualify if:

• Mothers of children with moderate to severe birth asphyxia or gross congenital anomalies
• Mothers who are unable to communicate to provide information

Sponsors & Collaborators

• University of Ibadan: lead
• Grand Challenges Canada: collaborator

Study Officials

• Akindele O Adebiyi, MBchB, MPH

  College of Medicine University of Ibadan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator, College of Medicine Research and innovation Management Unit

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 3, 2016
• Study Start: November 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 6, 2019

Record last verified: 2019-02