Responsive Parenting Program for Infants in Rural Bangladesh

Child Development Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466933
• Other study ID #: REB#420-0510
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: July 16, 2013
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Bangladesh Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 14 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Development

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bangladesh	Save the Children district office	Kushtia

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Save the Children

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bayley scales of infant development	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	No
Secondary	HOME Inventory	45 items assessing through observation and interview opportunities for stimulation in the home.	12 months	No
Secondary	Mother-Child picture talk	Mothers' responsive talk while looking at pictures with her child.	12 months	No
Secondary	Dietary diversity	Number out of 7 categories of food, based on Mothers recall foods fed to their child over a 24-hour period.	12 months	No
Secondary	Child development knowledge of mother	Mothers report the age when they expect children to start acquiring 10 psychosocial skills, e.g. recognize its mother.	12 months	No
Secondary	height for age	height for age z score is derived from the current WHO growth standards	12 months	No