Responsive Parenting Program for Infants in Rural Bangladesh

July 16, 2013 updated by: Frances Aboud, McGill University

Design, Implementation and Evaluation of a Parent Support/Counselling Program With a Focus on Responsive Stimulation for Infants and Young Children in Rural Bangladesh

Children of mothers in the intervention parenting program are expected to show benefits over the standard care control group in terms of better cognitive/language development, less recent illness, and better height for age. The mothers assigned to the intervention parenting program are expected to evidence higher levels of home stimulation, better health prevention, and better dietary diversity, along with more accurate knowledge of child development.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are actually two intervention groups: in one the program is delivered by trained peer educators from the village, and in the other the program is delivered by trained government personnel.

Study Type

Interventional

Enrollment (Actual)

474

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Kushtia, Bangladesh
        • Save the Children district office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mother has a child 6 to 14 months of age
  • mother willing to learn about child care

Exclusion Criteria:

  • not severely disabled

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community-based
Community trained peer educator delivers parenting sessions to mothers in the village on a monthly basis
Behavioral: Responsive parenting
On a monthly basis, mothers meet with the peer educator to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development. Mothers practice with their child and are coached by the peer educator.
Active Comparator: Government-based
Government community health workers, trained, deliver the intervention to mothers in the village
Behavioral: Child Development
On a monthly basis, mothers meet with the government worker to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development.
No Intervention: Control
Mothers receive the standard care which is a visit from the health worker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bayley scales of infant development
Time Frame: 12 months
Cognitive, receptive language and expressive language items will be administered to the child and scored as pass/fail with a total score calculated for each subtest and the total.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOME Inventory
Time Frame: 12 months
45 items assessing through observation and interview opportunities for stimulation in the home.
12 months
Mother-Child picture talk
Time Frame: 12 months
Mothers' responsive talk while looking at pictures with her child.
12 months
Dietary diversity
Time Frame: 12 months
Number out of 7 categories of food, based on Mothers recall foods fed to their child over a 24-hour period.
12 months
Child development knowledge of mother
Time Frame: 12 months
Mothers report the age when they expect children to start acquiring 10 psychosocial skills, e.g. recognize its mother.
12 months
height for age
Time Frame: 12 months
height for age z score is derived from the current WHO growth standards
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

Save the Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 16, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REB#420-0510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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