A Community Based Implementation of a Toolkit and Parenting Program for Improving Brain Development in Newborns
NCT ID: NCT02290756
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1080 participants
INTERVENTIONAL
2015-01-31
2016-09-30
Brief Summary
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Detailed Description
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Through this project, two intervention packages will be implemented. Firstly the toolkit will be provided to all 1080 pregnant women recruited in both the intervention and control arm of the project. The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
1. Gloves, Soap, a plastic sheet, a new razor blade, clean thread or narrow tape, cord clamp, aspiration bulb, bag and mask provision to the BAs, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials
2. Trainings for Birth Attendants and Link workers on aspiration and hypothermia management techniques, use of bag and mask, APGAR (also to parents), cord care, basic pregnancy care and newborn care related information, danger signs during pregnancy, postpartum, for the newborn and during the neonatal and infancy.
The second intervention package will be the implementation of the parenting program through the link workers and parents to the newborns-followed monthly over a 12 month period and will be provided to 540 women only in the intervention arm of the study. The aim of this intervention is to improve brain development among newborns through the parenting program. The Curriculum for Child Development will be adapted to the community context and used. The curriculum will be developed in the first 6 months of the project and will be designed to include:
* Monthly lessons for the parents-this will include both group and individual sessions. The parents will have one group session and one follow-up individual session respectively.
* Training guides, materials/tools and diaries for the link workers to use to log the sessions The parenting program will be implemented by the Link Workers.
Project Implementation:
The project will proceed in two phases. In Phase 1 (first two months of the project) a community assessment will be conducted, operational plans finalized, development of tools, jobs aids, IEC materials, recruiting and trainings of the link workers and TBAs and other community based birth attendants. Furthermore, linkages with LHWs will be developed at this stage. The implementation toolkits will also be prepared, with all tangible elements procured in Pakistan.
Phase 2 will focus on implementing, monitoring and documenting interventions. In the first two months of Phase 2, pregnant mothers (who will be at the beginning of their second trimester) will be recruited in both arms of the study. Recruitment will be conducted by Birth Attendants and Link Workers through the listing of pregnant women developed in consultation with various formal and informal care providers in the community. Recruitment of women will be limited to these two months. Once recruited, the women will be followed for the duration of their pregnancy and through the first year of the newborn's life. Pregnant women will be provided services included in the toolkit including nutritional supplementation. In addition, the items of the toolkit that is essential for delivery such as the Clean Delivery Kit, Chlorhexidine and Misoprostol will be provided two months before the expected delivery date of each pregnant woman. Birth attendants trained through the project will deliver the home based deliveries that will take place in the communities. Referral networks will be established with referral health facilities in case of complications. Once the newborn is delivered, those in the intervention arm of the study will be provided the parenting program for the next 12 months. The newborns in the control arm will not be provided the parenting program, but will continue to receive the standard health care services provided through routine home-based visits of Lady Health Workers. Both the intervention and control groups will undergo assessments at varying times during the 12 month period when the parenting program will be implemented in the intervention group. These assessments will include assessing the parent-child interaction and conducting the home inventory test periodically starting from when the newborn is six months old. The Bayleys Scale for Infant Development-III will also be implemented on one year old infants (cognition, motor and language subtests) in both project arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Parenting program and toolkit
The intervention arm of the study will have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy and the parenting program delivered to the newborn for 12 months.
Parenting Program
The parenting program is an early childhood stimulation program aimed at newborns from their neonatal period till infancy. The implementation of the parenting program will be conducted through the link workers and parents of the newborns.
Low cost evidence based toolkit
The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
1. Clean delivery kit, aspiration bulb, bag and mask, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials
2. Trainings for Birth Attendants and Link workers on aspiration and hypothermia management techniques, use of bag and mask APGAR (also to parents), cord care, basic pregnancy and newborn care information
Control- toolkit
The control arm of the study will only have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy.
Low cost evidence based toolkit
The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
1. Clean delivery kit, aspiration bulb, bag and mask, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials
2. Trainings for Birth Attendants and Link workers on aspiration and hypothermia management techniques, use of bag and mask APGAR (also to parents), cord care, basic pregnancy and newborn care information
Interventions
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Parenting Program
The parenting program is an early childhood stimulation program aimed at newborns from their neonatal period till infancy. The implementation of the parenting program will be conducted through the link workers and parents of the newborns.
Low cost evidence based toolkit
The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
1. Clean delivery kit, aspiration bulb, bag and mask, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials
2. Trainings for Birth Attendants and Link workers on aspiration and hypothermia management techniques, use of bag and mask APGAR (also to parents), cord care, basic pregnancy and newborn care information
Eligibility Criteria
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Inclusion Criteria
2. Those women who will continue to live in the community/village during the pregnancy period and until one year postpartum.
Exclusion Criteria
2. Not willing to participate in the study/unwilling to provide informed consent or the consent of their family.
ALL
Yes
Sponsors
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Grand Challenges Canada
OTHER
Centre for Global Public Health Pakistan
OTHER
University of Manitoba
OTHER
Responsible Party
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Dr. James F. Blanchard
Center Director
Principal Investigators
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James F Blanchard, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Tahira E Reza, MSc
Role: PRINCIPAL_INVESTIGATOR
Centre for Global Public Health Pakistan
Locations
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Center for Global Public Health
Islamabad, , Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H2014:301
Identifier Type: -
Identifier Source: org_study_id