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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01906606
Other study ID # REB#231-1112
Secondary ID
Status Completed
Phase N/A
First received July 3, 2013
Last updated March 17, 2016
Start date January 2013
Est. completion date February 2014

Study information

Verified date March 2016
Source McGill University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The purpose of the current study involves the development, implementation and evaluation of a parenting program to target maternal well-being and child health, growth and development in Lira, Uganda. The current study aims to address maternal care within a parenting program as well as parenting practices emphasizing nutrition, hygiene, and psychosocial stimulation through peer-support, practice and problem-solving. Outcomes include child health, growth and development, maternal mental health, mother-child interactions, and maternal-spousal relations.

We hypothesize that:

1. Children of parents who attend the parenting program will have better health, height and cognitive/language development at post-test, than children whose parents did not have the opportunity to attend parenting sessions.

2. Parents who attend the parenting program will have more knowledge about child development and provide more home stimulation, dietary diversity and preventive health practices than parents who do not have the opportunity to attend parenting sessions.

3. Mothers who attend the parenting program will have improved well-being compared to mothers who do not have the opportunity to attend parenting sessions.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date February 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 36 Months
Eligibility Inclusion Criteria:

- mothers of children ages 12-24 months

Exclusion Criteria:

- disabled children

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Parenting Program
A manualized, community-based 12 session group parenting program, facilitated by a locally recruited volunteer

Locations

Country Name City State
Uganda Lira Program Unit, Plan Uganda Lira

Sponsors (2)

Lead Sponsor Collaborator
McGill University Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from Baseline in child length-for-age length for age Baseline and 11 months No
Primary Change from baseline in Bayley III Language scale receptive and expressive language subtests Baseline and 11 months No
Secondary Change from baseline in CES-D maternal depressive symptoms (CES-D) and perceived positive and negative support Baseline and 11 months No
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