Infant DevelopmentNCT02290756
A Community Based Implementation of a Toolkit and Parenting Program for Improving Brain Development in Newborns
A study testing Parenting Program and Low cost evidence based toolkit in people with Infant Development, run by University of Manitoba at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Parenting Program and Low cost evidence based toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2015to Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Those pregnant women who are starting the second trimester of their pregnancy;
- Those women who will continue to live in the community/village during the pregnancy period and until one year postpartum.
Who cannot join
- 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.)
- Not willing to participate in the study/unwilling to provide informed consent or the consent of their family.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Center for Global Public Health
Islamabad, 44000
Momina Salim, MPH, +92-302-8558590, momina.salim@live.com
Tahira E Reza, MSc, reza.tahira@gmail.com
About this study
Official title: A Community Based Implementation of a Low Cost Evidence-based Toolkit and Parenting Program for Improving Brain Development in Newborns
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.
Read the detailed description
Intervention:
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:
- 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
- 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
- Infant Development
- Being tested
- Parenting Program, Low cost evidence based toolkit
- Keywords
- Early child development, Link Workers, Community Birth attendants, Parenting Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting ProgramBehavioural
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 toolkitBehavioural
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:
- Clean delivery kit, aspiration bulb, bag and mask, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials
- 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
| Study group | Role | What they receive |
|---|---|---|
| Parenting program and toolkit | Active comparator | 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. Receives: Behavioral: Parenting Program; Behavioral: Low cost evidence based toolkit |
| Control- toolkit | Other | 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. Receives: Behavioral: Low cost evidence based toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Bayleys Scale for Infant Development score
Measured: one time assessment at infant's 12 month birthday
Secondary outcomes (2)
HOME inventory test
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.
Measured: 2 assessments at 6 months birthday and 12 month birthday of the infant
Parent-Child Interaction assessment
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.
Measured: 2 assessments at 6 months birthday and 12 month birthday of the infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, Centre for Global Public Health Pakistan
- Responsible party
- Principal investigator, Dr. James F. Blanchard, University of Manitoba
- Investigators
- James F Blanchard, MSc, Principal investigator, University of ManitobaTahira E Reza, MSc, Principal investigator, Centre for Global Public Health Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290756
- Sponsor's protocol ID
- H2014:301
- Status last verified
- Nov 2015
- First submitted
- 21 Oct 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Based Implementation of a Low Cost Evidence-based Toolkit and Parenting Program for Improving Brain Development in Newborns
- ClinicalTrials.gov ID
- NCT02290756
- Acronym / sponsor ID
- H2014:301
- Conditions
- Infant Development
- Keywords
- Early child development, Link Workers, Community Birth attendants, Parenting Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, Centre for Global Public Health Pakistan
- Study start
- Jan 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 14 Nov 2014 (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.
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.
Detailed description
Intervention:
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:
- 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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting program and toolkit | Active comparator | Behavioral: Parenting Program, Behavioral: Low cost evidence based toolkitThe 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. |
| Control- toolkit | Other | Behavioral: Low cost evidence based toolkitThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Those pregnant women who are starting the second trimester of their pregnancy;
- Those women who will continue to live in the community/village during the pregnancy period and until one year postpartum.
Key exclusion criteria (2 listed)
- 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.)
- Not willing to participate in the study/unwilling to provide informed consent or the consent of their family.
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 |
|---|---|---|
| Parenting ProgramThe 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. | Behavioural | Parenting program and toolkit |
| Low cost evidence based toolkitThe 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 | Behavioural | Control- toolkit, Parenting program and toolkit |
Primary outcome
Improvement in Bayleys Scale for Infant Development score
Time frame: one time assessment at infant's 12 month birthday
2 secondary outcomes
HOME inventory test
Time frame: 2 assessments at 6 months birthday and 12 month birthday of the infant
Parent-Child Interaction assessment
Time frame: 2 assessments at 6 months birthday and 12 month birthday of the infant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
James F Blanchard, MSc principal investigator
University of Manitoba
Tahira E Reza, MSc principal investigator
Centre for Global Public Health Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Program and Low cost evidence based toolkit in people with Infant Development, run by University of Manitoba at 1 site in Pakistan.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James F Blanchard, MSc ((204) 977-5603, james_blanchard@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Bayleys Scale for Infant Development score (time frame: one time assessment at infant's 12 month birthday). 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 2 Dec 2015.