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Completed

NCT Number: NCT02697110

Family Inclusive Early Brain Stimulation

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.

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Key information

Conditions

Brain Stimulation

Age range

1 week–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edutainment based intervention

Behavioral

Edutainment intervention package

Primary outcomes

  1. 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

    Reduced socio-cognitive deficit in the intervention compared to the control group at 18 months of age

  2. Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire

    Time frame: 18 months

    Improved child stimulation practices in the intervention compared to the control group at 18 months of age

  3. 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

    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

Secondary outcomes

  1. 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

    An increase in mothers knowledge and competence on child brain stimulation practices

  2. 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

    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.

  3. 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

    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)

  4. 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

    The competence and knowledge of health workers to successfully deliver intervention this intervention after being trained would also be a secondary measure of success.

Sponsors and collaborators

Lead sponsor

University of Ibadan

Other

Collaborators

  • Grand Challenges Canada

Registry information

Acronym: FINEBRAINS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2016
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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