Responsive Parenting Program for Infants in Rural Bangladesh

This study has been completed.
Sponsor:
Collaborator:
Save the Children
Information provided by (Responsible Party):
Frances Aboud, McGill University
ClinicalTrials.gov Identifier:
NCT01466933
First received: November 4, 2011
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Child Development
Behavioral: Responsive parenting
Behavioral: Child Development

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Design, Implementation and Evaluation of a Parent Support/Counselling Program With a Focus on Responsive Stimulation for Infants and Young Children in Rural Bangladesh

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Bayley scales of infant development [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • HOME Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    45 items assessing through observation and interview opportunities for stimulation in the home.

  • Mother-Child picture talk [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mothers' responsive talk while looking at pictures with her child.

  • Dietary diversity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number out of 7 categories of food, based on Mothers recall foods fed to their child over a 24-hour period.

  • Child development knowledge of mother [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mothers report the age when they expect children to start acquiring 10 psychosocial skills, e.g. recognize its mother.

  • height for age [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    height for age z score is derived from the current WHO growth standards


Enrollment: 474
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not severely disabled
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466933

Locations
Bangladesh
Save the Children district office
Kushtia, Bangladesh
Sponsors and Collaborators
McGill University
Save the Children
Investigators
Principal Investigator: Frances Aboud, PhD McGill University
  More Information

No publications provided

Responsible Party: Frances Aboud, Professor, McGill University
ClinicalTrials.gov Identifier: NCT01466933     History of Changes
Other Study ID Numbers: REB#420-0510
Study First Received: November 4, 2011
Last Updated: July 16, 2013
Health Authority: Bangladesh: Bangladesh Medical Research Council

Keywords provided by McGill University:
parenting intervention
child development
low and middle income countries

ClinicalTrials.gov processed this record on August 26, 2014