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Clinical Trials/NCT01466933
NCT01466933CompletedNot Applicable

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

McGill University1 site in 1 country474 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
474
Locations
1
Primary Endpoint
Bayley scales of infant development

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
6 Months to 14 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •not severely disabled

Arms & Interventions

Community-based

Experimental

Community trained peer educator delivers parenting sessions to mothers in the village on a monthly basis

Intervention: Responsive parenting (Behavioral)

Government-based

Active Comparator

Government community health workers, trained, deliver the intervention to mothers in the village

Intervention: Child Development (Behavioral)

Control

No Intervention

Mothers receive the standard care which is a visit from the health worker

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • HOME Inventory(12 months)
  • Mother-Child picture talk(12 months)
  • Dietary diversity(12 months)
  • Child development knowledge of mother(12 months)
  • height for age(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Frances Aboud

Professor

McGill University

Study Sites (1)

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