Family Inclusive Early Brain Stimulation (FINEBRAINS)

U

University of Ibadan

Status

Completed

Conditions

Brain Stimulation

Treatments

Behavioral: Edutainment based intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02697110
AD/13/479/741

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 patients

Sex

All

Ages

1 to 6 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

480 participants in 2 patient groups

A: Edutainment based intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Edutainment based intervention
B
No Intervention group
Description:
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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