Family Inclusive Early Brain Stimulation (FINEBRAINS)
2019년 2월 4일 업데이트: Dr. A.O. Adebiyi, University of Ibadan
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
480
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
1주 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: A: Edutainment based intervention
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.
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Edutainment intervention package
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간섭 없음: B
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
기간: 6weeks, 14 weeks, 9months, 12 months and 18 months
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Reduced socio-cognitive deficit in the intervention compared to the control group at 18 months of age
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6weeks, 14 weeks, 9months, 12 months and 18 months
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Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire
기간: 18 months
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Improved child stimulation practices in the intervention compared to the control group at 18 months of age
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18 months
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Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards
기간: 6weeks to 18 months
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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
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6weeks to 18 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument
기간: 9mths -12 months
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An increase in mothers knowledge and competence on child brain stimulation practices
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9mths -12 months
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Mothers engagement of fathers and other caregivers on early brain stimulation as measured by simple questionnaire on mothers self-reported father engagement activity
기간: 6-18months
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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.
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6-18months
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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
기간: 18 months
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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)
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18 months
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Increased knowledge and competence of health workers on early brain stimulation as measured by study derived composite questionnaire on knowledge and competence on intervention
기간: 14weeks - 9months
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The competence and knowledge of health workers to successfully deliver intervention this intervention after being trained would also be a secondary measure of success.
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14weeks - 9months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Akindele O Adebiyi, MBchB, MPH, College of Medicine, University of Ibadan
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 11월 1일
기본 완료 (실제)
2016년 8월 1일
연구 완료 (실제)
2016년 8월 1일
연구 등록 날짜
최초 제출
2016년 2월 22일
QC 기준을 충족하는 최초 제출
2016년 2월 25일
처음 게시됨 (추정)
2016년 3월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 2월 4일
마지막으로 확인됨
2019년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .