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Effectiveness of Parenting Programs on Child Development and Maternal Well-being in Rural Uganda

Primary Purpose

Child Development, Depression

Status

Completed

Phase

Not Applicable

Locations

Uganda

Study Type

Interventional

Intervention

Parenting Program

About this trial

This is an interventional health services research trial for Child Development focused on measuring child nutritional status, child development, maternal depression

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

mothers of children ages 12-24 months

Exclusion Criteria:

disabled children

Sites / Locations

Lira Program Unit, Plan Uganda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parenting Program

Control Group

Arm Description

12 session community-based parenting program

received visual aids on nutrition

Outcomes

Primary Outcome Measures

Change from baseline in Bayley III Language scale

receptive and expressive language subtests

Secondary Outcome Measures

Change from baseline in CES-D

maternal depressive symptoms (CES-D) and perceived positive and negative support

Full Information

NCT ID

NCT01906606

First Posted

July 3, 2013

Last Updated

March 17, 2016

Sponsor

McGill University

Collaborators

Mbarara University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT01906606

Brief Title

Effectiveness of Parenting Programs on Child Development and Maternal Well-being in Rural Uganda

Official Title

Effectiveness of Parenting Programs on Child Development and Maternal Well-being in Rural Uganda

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McGill University

Collaborators

Mbarara University of Science and Technology

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Child Development, Depression

Keywords

child nutritional status, child development, maternal depression

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parenting Program

Arm Type

Experimental

Arm Description

12 session community-based parenting program

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

received visual aids on nutrition

Intervention Type

Behavioral

Intervention Name(s)

Parenting Program

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in Bayley III Language scale

Description

receptive and expressive language subtests

Time Frame

Baseline and 11 months

Secondary Outcome Measure Information:

Title

Change from baseline in CES-D

Description

maternal depressive symptoms (CES-D) and perceived positive and negative support

Time Frame

Baseline and 11 months

Other Pre-specified Outcome Measures:

Title

Change from Baseline in child length-for-age

Description

length for age

Time Frame

Baseline and 11 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

36 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: mothers of children ages 12-24 months Exclusion Criteria: disabled children

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frances Aboud, PhD

Organizational Affiliation

McGill University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lira Program Unit, Plan Uganda

City

Lira

Country

Uganda

12. IPD Sharing Statement

Citations:

PubMed Identifier

26144389

Citation

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. Erratum In: Lancet Glob Health. 2016 Jan;4(1):e28.

Results Reference

derived

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Effectiveness of Parenting Programs on Child Development and Maternal Well-being in Rural Uganda

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