NCT01906606

Brief 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

July 3, 2013

Last Update Submit

March 17, 2016

Conditions

Keywords

child nutritional statuschild developmentmaternal depression

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Bayley III Language scale

    receptive and expressive language subtests

    Baseline and 11 months

Secondary Outcomes (1)

  • Change from baseline in CES-D

    Baseline and 11 months

Other Outcomes (1)

  • Change from Baseline in child length-for-age

    Baseline and 11 months

Study Arms (2)

Parenting Program

EXPERIMENTAL

12 session community-based parenting program

Behavioral: Parenting Program

Control Group

NO INTERVENTION

received visual aids on nutrition

Interventions

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

Parenting Program

Eligibility Criteria

Age12 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • mothers of children ages 12-24 months

You may not qualify if:

  • disabled children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lira Program Unit, Plan Uganda

Lira, Uganda

Location

Related Publications (1)

  • Singla DR, Kumbakumba E, Aboud FE. Effects of a parenting intervention to address maternal psychological wellbeing and child development and growth in rural Uganda: a community-based, cluster randomised trial. Lancet Glob Health. 2015 Aug;3(8):e458-e469. doi: 10.1016/S2214-109X(15)00099-6. Epub 2015 Jul 2.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Frances Aboud, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 24, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

March 18, 2016

Record last verified: 2016-03

Locations