Family Inclusive Early Brain Stimulation

Brain Stimulation Clinical Trial

— FINEBRAINS  

Official title:

Family Inclusive Early Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697110
• Other study ID #: AD/13/479/741
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2019
• Source: University of Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Brain Stimulation

Intervention

Behavioral:
• Edutainment based intervention
Edutainment intervention package

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Ibadan	Grand Challenges Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	9mths -12 months
Secondary	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.	6-18months
Secondary	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)	18 months
Secondary	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.	14weeks - 9months