Employing general practitioners for delivering a child development package in Pakistan

• Register: ISRCTN
• Last refreshed on: 10 December 2019
• Main ID: ISRCTN48032200
• Date of registration: 31/12/2014
• Prospective Registration: Yes
• Primary sponsor: Grand Challenges Canada
• Public title: Employing general practitioners for delivering a child development package in Pakistan
• Scientific title: A sustainable public-private partnership for delivering integrated child development care in Pakistan: a clustered randomized controlled trial
• Date of first enrolment: 01/02/2015
• Target sample size: 2200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN48032200
• Study type: Interventional
• Study design: Randomized controlled cluster trial with two arms (Other)
• Phase: Not Applicable

Countries of recruitment

Pakistan

Contacts

• Name: Muhammad Amir Khan

Key inclusion & exclusion criteria

Inclusion criteria: All mother-infant dyads =1 month of full-term (=36 weeks) delivery within catchment area (no migration during tenure of trial)
Exclusion criteria:
Child known to have congenital abnormality, history of delayed cry or seizures, cretinism, low birth weight
<2500 g, death of either mother or child


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Child development, maternal depression, child nutrition
Not Applicable

Intervention(s)

Intervention 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

Primary Outcome(s)

Reduction 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(s)

1. 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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Grand Challenges Canada

Ethics review

Status:
Approval date:
Contact:

NBC 154, National Bioethics Committee Pakistan, 11/09/2014

Results

• Results available: Yes
• Date Completed: 30/09/2016