Family Inclusive Early Brain Stimulation

NCT ID: NCT02697110

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-08-31

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.

Conditions

Brain Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

A: Edutainment based intervention

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.

Group Type: EXPERIMENTAL

Edutainment based intervention

Intervention Type: BEHAVIORAL

Edutainment intervention package

B

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Edutainment based intervention

Edutainment intervention package

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 6 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grand Challenges Canada

OTHER

Sponsor Role: collaborator

University of Ibadan

OTHER

Sponsor Role: lead

Responsible Party

Dr. A.O. Adebiyi

Coordinator, College of Medicine Research and innovation Management Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akindele O Adebiyi, MBchB, MPH

Role: PRINCIPAL_INVESTIGATOR

College of Medicine University of Ibadan

Other Identifiers

AD/13/479/741

Identifier Type: -

Identifier Source: org_study_id