NCT01466933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
474

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 18, 2013

Status Verified

July 1, 2013

Enrollment Period

1.2 years

First QC Date

November 4, 2011

Last Update Submit

July 16, 2013

Conditions

Child Development

Keywords

parenting interventionchild developmentlow and middle income countries

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

Study Arms (3)

Community-based

EXPERIMENTAL

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

Behavioral: Responsive parenting

Government-based

ACTIVE COMPARATOR

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

Behavioral: Child Development

Control

NO INTERVENTION

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

Interventions

Responsive parentingBEHAVIORAL

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.

Community-based
Child DevelopmentBEHAVIORAL

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.

Government-based

Eligibility Criteria

Age6 Months - 14 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • not severely disabled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Save the Children district office

Kushtia, Bangladesh

Location

MeSH Terms

Interventions

Child Development

Intervention Hierarchy (Ancestors)

Human DevelopmentGrowth and DevelopmentPhysiological Phenomena

Study Officials

  • Frances Aboud, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 8, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 18, 2013

Record last verified: 2013-07

Locations

BA(1)