Perinatal Depression Treatment and Child Development

NCT ID: NCT01826903

Last Updated: 2015-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

964 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-10-31

Brief Summary

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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

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Conditions

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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depressed mother/child dyad - intervention

No interventions assigned to this group

depressed mother/child dyad - no intervention

No interventions assigned to this group

non-depressed mother/child dyad

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* developmental disability, visual or hearing impairment
Minimum Eligible Age

6 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Human Development Research Foundation, Pakistan

OTHER

Sponsor Role collaborator

Grand Challenges Canada

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanna Maselko, ScD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Siham Sikander, PhD

Role: PRINCIPAL_INVESTIGATOR

Human Development Research Foundation, Pakistan

Locations

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Human Development Research Foundation

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

References

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Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008 Sep 13;372(9642):902-9. doi: 10.1016/S0140-6736(08)61400-2.

Reference Type BACKGROUND
PMID: 18790313 (View on PubMed)

Other Identifiers

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Saving Brains #0058

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ISRCTN65316374

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pro00034166

Identifier Type: -

Identifier Source: org_study_id

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