Trials / Completed
CompletedNCT02697110
Family Inclusive Early Brain Stimulation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 480 (actual)
- Sponsor
- University of Ibadan · Academic / Other
- Sex
- All
- Age
- 1 Week – 6 Weeks
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Edutainment based intervention | Edutainment intervention package |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2016-03-03
- Last updated
- 2019-02-06
Source: ClinicalTrials.gov record NCT02697110. Inclusion in this directory is not an endorsement.