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A Community Based Implementation of a Toolkit and Parenting Program for Improving Brain Development in Newborns

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ClinicalTrials.gov Identifier: NCT02290756
Recruitment Status : Unknown
Verified November 2015 by Dr. James F. Blanchard, University of Manitoba.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborators:
Grand Challenges Canada
Center for Global Public Health Pakistan
Information provided by (Responsible Party):
Dr. James F. Blanchard, University of Manitoba

Brief Summary:
The investigators propose to develop and test the efficacy of a low cost evidence based toolkit aimed at improving brain development among newborns a rural setting of Pakistan. The toolkit will include a safe delivery kit, nutritional supplementation, and trainings on cord care, hypothermia management, aspiration and bag and mask techniques and APGAR score calculation. A simple, home-based parenting program will also be implemented that will teach parents tools that provide stimuli for brain and cognitive development in children. This parenting program covers Early Childhood Interventions for children at risk of developmental problems and covers developmental skill areas such as cognitive and fine motor, social and self-help and gross motor skills. Such an intervention package provides comprehensive care to families at the community level, with a minimal cost that can be scaled up. A new cadre of Link workers will be implemented who will provide mentoring and supportive supervision to Birth Attendants and will train parents in the stimulation program. The study will recruit 1080 pregnant women and their newborns.

Condition or disease Intervention/treatment Phase
Infant Development Behavioral: Parenting Program Behavioral: Low cost evidence based toolkit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Community Based Implementation of a Low Cost Evidence-based Toolkit and Parenting Program for Improving Brain Development in Newborns
Study Start Date : January 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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.

Behavioral: 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.
Behavioral: 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




Primary Outcome Measures :
  1. Improvement in Bayleys Scale for Infant Development score [ Time Frame: one time assessment at infant's 12 month birthday ]

Secondary Outcome Measures :
  1. HOME inventory test [ Time Frame: 2 assessments at 6 months birthday and 12 month birthday of the infant ]
    The Infant/Toddler (IT) HOME Inventory is designed for use during infancy (birth to age three). It is composed of 45 items clustered into six subscales: 1) Parental Responsivity, 2) Acceptance of Child, 3) Organization of the Environment, 4) Learning Materials, 5) Parental Involvement, and 6) Variety in Experience. Each inventory contains a group of scales to assess different aspects of the child's environment. Each scale contains a number of items that are scored according to a glossary. The HOME therefore provides a framework for interviewers to assess all aspects of the home environment, including parenting, that directly impact on the child.

  2. Parent-Child Interaction assessment [ Time Frame: 2 assessments at 6 months birthday and 12 month birthday of the infant ]

    This tool will consist of a checklist that will observe the different behaviors of the mother, while the child is given an object to play with. It looks at the mother's sensitivity to the child's needs. In addition, this questionnaire also observes the mother's effort to help a child to maintain interest level in that particular game.

    Another checklist aimed at observing the infant will be used to observe the infant's response to the game the mother wants to play with e.g, excitement and enjoyment like clapping etc. Observation of the child's communication towards the mother and the game will also be assessed, to see whether the response is positive, negative, and to see what effort the child makes to communicate.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Those pregnant women who are starting the second trimester of their pregnancy;
  2. Those women who will continue to live in the community/village during the pregnancy period and until one year postpartum.

Exclusion Criteria:

  1. Those pregnant women who appear to be, in the link worker's judgment, incapable of understanding the information provided about the study (e.g., mentally incapacitated, cognitively impaired etc.)
  2. Not willing to participate in the study/unwilling to provide informed consent or the consent of their family.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290756


Contacts
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Contact: James F Blanchard, MSc (204) 977-5603 james_blanchard@umanitoba.ca
Contact: Momina Salim, MPH +92-302-8558590 momina.salim@live.com

Locations
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Pakistan
Center for Global Public Health Recruiting
Islamabad, Pakistan, 44000
Contact: Momina Salim, MPH    +92-302-8558590    momina.salim@live.com   
Contact: Tahira E Reza, MSc       reza.tahira@gmail.com   
Sponsors and Collaborators
University of Manitoba
Grand Challenges Canada
Center for Global Public Health Pakistan
Investigators
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Principal Investigator: James F Blanchard, MSc University of Manitoba
Principal Investigator: Tahira E Reza, MSc Center for Global Public Health Pakistan
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Responsible Party: Dr. James F. Blanchard, Center Director, University of Manitoba
ClinicalTrials.gov Identifier: NCT02290756    
Other Study ID Numbers: H2014:301
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Dr. James F. Blanchard, University of Manitoba:
Early child development
Link Workers
Community Birth attendants
Parenting Program