Employing general practitioners for delivering a child development package in Pakistan

ISRCTN ISRCTN48032200
DOI https://doi.org/10.1186/ISRCTN48032200
Secondary identifying numbers N/A
Submission date
18/11/2014
Registration date
31/12/2014
Last edited
01/11/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Early child development is dependent on the mother’s ability to provide the right physical and social environment and support to her young child. In Pakistan, like most developing countries, early child development has been a grossly neglected area of public health importance, where the main challenges include tackling the problem of high numbers of children suffering from chronic malnutrition, the low level of mothers’ skills for child development, and maternal mental health problems. Child malnutrition and the mother’s caring ability (including her mental health) are considered to contribute significantly to the delayed development of child milestones: this is mainly due to under-weight births, poor breastfeeding and weaning practice, and recurrent infections. It is suggested that these are linked to low literacy, psychosocial factors and lack of counselling for maternal mental health problems. In poor urban settings, the mothers’ ability to cater for child development needs is constrained by their low literacy, poor mental health and lack of skills. The aim of the study is to develop and evaluate a set of infant nutrition and development products along with maternal mental health products that could be implemented in poor urban settlements. For this purpose private clinics will be employed to promote the development of poor urban infants (age ≤ 1 year). The main objectives are to:
1. Develop an integrated early child development (infant) care package with three key components: infant development, nutrition counselling, and maternal mental health.
2. Arrange, implement and monitor the care products at 22 selected private clinics in poor urban localities.
3. Design and conduct a study to evaluate the effectiveness and feasibility of the intervention.

Who can participate?
Mothers with infants who were delivered within 1 month of full-term (≥36 weeks) and who live within the catchment area of the study.

What does the study involve?
The selected 22 private clinics are randomly allocated into one of two groups. Those mothers and infants attending clinics in group 1 (intervention group) are given the designed products for nutrition, early child development and maternal depression. Mothers and infants attending clinics in group 2 (control group) receive the usual care.

What are the possible benefits and risks of participating?
It has been assumed that the intervention group will benefit from the products introduced at the clinics with better infant nutrition and better progress for developmental milestones. The control group will not be deprived of any care or referral needed to minimize any risk or ethical issue.

Where is the study run from?
Association for Social Development (Pakistan).

When is the study starting and how long is it expected to run for?
October 2014 to September 2016.

Who is funding the study?
Grand Challenges Canada (Canada)

Who is the main contact?
Dr Muhammad Amir Khan
asd@asd.com.pk

Study website

Contact information

Dr Muhammad Amir Khan
Scientific

Association for Social Development
House No. 12
Street 48, F-7/4
Islamabad
44000
Pakistan

Phone +92 (0) 51 2611231
Email asd@asd.com.pk

Study information

Study designRandomized controlled cluster trial with two arms
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Not specified
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA sustainable public-private partnership for delivering integrated child development care in Pakistan: a clustered randomized controlled trial
Study acronymN/A
Study objectivesPrimary hypothesis: the introduction of context-sensitive early child development (ECD) packages will reduce childhood development delay (i.e., motor skills: from 20% to 16%; cognition: from 10% to 03%; and language:
from 30% to 22%) in the catchment area.

Secondary hypotheses:
1. There will be a decrease in the prevalence of maternal depression from 36% to 29% through a counseling
package facilitated by General Practitioner's Paramedic
2. Promotion of nutrition packages and medications will lead to a reduction in stunting prevalence (2SD HAZ)
Ethics approval(s)NBC 154, National Bioethics Committee Pakistan, 11/09/2014
Health condition(s) or problem(s) studiedChild development, maternal depression, child nutrition
InterventionIntervention arm:
1. Developing context-sensitive intervention products through TWG (including guidelines, training and
counseling tool)
2. Mapping and selection of priority locations and a private clinic in each selected location
3. Training of doctors and paramedics at selected private clinics for ECD, Maternal Health and Nutrition
4. Identifying and enabling of community advocates (for enhanced ECD care access)
5. Branding of selected private clinics
6. Identifying and recruiting (by doctor) eligible mother-child dyads, and keeping essential baseline record
7. Conducting quarterly counseling sessions of mothers (by paramedic) at a private clinic (for promoting child
and maternal mental health)
8. Offering low-dose quarterly Vitamin A supplement, mainly as a client retention measure
9. Identifying nutritional and/or child brain development and/or maternal mental health deficiencies, and
prescribe remedial action
10. Making community aware (about ECD care) through enabled community advocates and clinic branding
11. Applying mobile phone technology for client compliance to the quarterly follow-up visits (including
retrieval of delayed clients)
12. Identifying and referring (by doctor) the child and/or mothers with need for specialist care
13. Conducting facility and district level monitoring events

Control arm:
Routine clinic practice
Intervention typeMixed
Primary outcome measureReduction in the percentage of early childhood development delays through the context-sensitive packages delivered. The primary outcomes will be measured according to the baseline i.e one month after delivery (infants less than or equal to one month of age; infant development, nutrition and maternal mental health will be assessed at this point). Subsequent measurements will be made at 3 months, 6 months, 9 months and endline at the 12th month.
Secondary outcome measures1. Decrease in the prevalence of maternal depression through counseling
2. Decrease in the prevalence of stunting through nutrition counseling
The secondary outcomes will be measured according to the baseline i.e one month after delivery (infants less than or equal to one month of age; infant development, nutrition and maternal mental health will be assessed at this point). Subsequent measurements will be made at 3 months, 6 months, 9 months and endline at the 12th month.
Overall study start date01/10/2014
Completion date30/09/2016

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants2,200 mother-infant dyads (1,100 in each arm) in 22 clusters (where clusters refer to General Practitioner clinics)
Key inclusion criteriaAll mother-infant dyads ≤1 month of full-term (≥36 weeks) delivery within catchment area (no migration during tenure of trial)
Key exclusion criteriaChild known to have congenital abnormality, history of delayed cry or seizures, cretinism, low birth weight
<2500 g, death of either mother or child
Date of first enrolment01/02/2015
Date of final enrolment01/11/2015

Locations

Countries of recruitment

  • Pakistan

Study participating centre

Association for Social Development
Islamabad
44000
Pakistan

Sponsor information

Grand Challenges Canada
Government

MaRS Centre
South Tower
101 College Street
Suite 406
Toronto
M5G 1L7
Canada

Phone +1 (0)41 673 6568
Email info@grandchallenges.ca
Website http://www.grandchallenges.ca/saving-brains/
ROR logo "ROR" https://ror.org/02snbhr24

Funders

Funder type

Government

Grand Challenges Canada
Government organisation / National government
Alternative name(s)
Grands Défis Canada, GCC
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planWe are intending to publish four papers: protocol paper, main trial paper, costing paper and a qualitative article.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 09/01/2017 01/11/2019 Yes No

Editorial Notes

01/11/2019: Publication reference added.