Brain StimulationFINEBRAINSNCT02697110
Family Inclusive Early Brain Stimulation
A study testing Edutainment based intervention in people with Brain Stimulation, run by University of Ibadan.
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. Read more about this study
- Who is it for?
- Ages 1 week to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Brain Stimulation
- What is being tested?
- Edutainment based intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All mothers with live children aged 1-6 weeks
Who cannot join
- Mothers of children with moderate to severe birth asphyxia or gross congenital anomalies
- Mothers who are unable to communicate to provide information
About this study
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.
Read the 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
- Being tested
- Edutainment based intervention
- Keywords
- Cognition, Brain Stimulation, Early Child Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edutainment based interventionBehavioural
Edutainment intervention package
| Study group | Role | What they receive |
|---|---|---|
| A: Edutainment based intervention | Experimental | 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. Receives: Behavioral: Edutainment based intervention |
| B | No intervention | This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6weeks, 14 weeks, 9months, 12 months and 18 months
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
Measured: 18 months
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
Measured: 6weeks to 18 months
Secondary outcomes (4)
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
Measured: 9mths -12 months
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.
Measured: 6-18months
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)
Measured: 18 months
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.
Measured: 14weeks - 9months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada
- Responsible party
- Principal investigator, Dr. A.O. Adebiyi, University of Ibadan
- Investigators
- Akindele O Adebiyi, MBchB, MPH, Principal investigator, College of Medicine University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697110
- Sponsor's protocol ID
- AD/13/479/741
- Acronym
- FINEBRAINS
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2016
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Decision would be based on research teams final decision after the crucial manuscripts have been published
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Inclusive Early Brain Stimulation
- ClinicalTrials.gov ID
- NCT02697110
- Acronym / sponsor ID
- FINEBRAINS / AD/13/479/741
- Conditions
- Brain Stimulation
- Keywords
- Cognition, Brain Stimulation, Early Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Collaborators
- Grand Challenges Canada
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Edutainment based intervention | Experimental | Behavioral: Edutainment based interventionThis 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. |
| B | No intervention | –This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months. |
Who may qualify
- Ages
- 1 week to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All mothers with live children aged 1-6 weeks
Key exclusion criteria (2 listed)
- Mothers of children with moderate to severe birth asphyxia or gross congenital anomalies
- Mothers who are unable to communicate to provide information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edutainment based interventionEdutainment intervention package | Behavioural | A: Edutainment based intervention |
Primary outcome
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
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
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: Undecided. Decision would be based on research teams final decision after the crucial manuscripts have been published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akindele O Adebiyi, MBchB, MPH principal investigator
College of Medicine University of Ibadan
Questions about this trial
What is this clinical trial studying?
A study testing Edutainment based intervention in people with Brain Stimulation, run by University of Ibadan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.