Perinatal Depression Treatment and Child Development

Completed

• Conditions: Depression

• Registration Number: NCT01826903
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to examine whether the successful perinatal depression intervention among mothers (Thinking Healthy Programme, THP) has led to improved developmental outcomes in the children 6 years later. Economic and human resources aspects of the intervention will also be evaluated to determine overall societal benefits from investment in such a program, feasibility of scaling up the intervention and its sustainability in the long-term. The primary hypothesis is that children of mothers who participated in the THP will have better cognitive outcomes and socio-emotional functioning when compared to children of mothers randomized to the control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-09
• Primary Completion: 2014-06
• Study Completion: 2014-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 964

Inclusion Criteria

• children of women who were eligible to participate in the Thinking Healthy Programme

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Exclusion Criteria

• developmental disability, visual or hearing impairment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate of general intelligence	Re-enrollment visit, approximately 7 years post-intervention
Measures of executive functions	Re-enrollment visit, approximately 7 years post-intervention	Working memory, cognitive flexibility, inhibitory control, and sustained attention will be measured by standard tests of cognitive functioning.
Level of literacy and numeracy	Re-enrollment visit, approximately 7 years post-intervention
Presence of behavioral and emotional problems (socio-emotional development)	Re-enrollment visit, approximately 7 years post-intervention

Secondary Outcome Measures

Name	Time	Method
Height-for-age	Re-enrollment visit, approximately 7 years post-intervention
Weight-for-age	Re-enrollment visit, approximately 7 years post-intervention

Trial Locations

Locations (1)

Human Development Research Foundation; 🇵🇰 Islamabad, Pakistan