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Completed

NCT Number: NCT01826903

Perinatal Depression Treatment and Child Development

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Human Development Research Foundation

Islamabad, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • developmental disability, visual or hearing impairment

Treatment and study plan

Primary outcomes

  1. Estimate of general intelligence

    Time frame: Re-enrollment visit, approximately 7 years post-intervention

  2. Measures of executive functions

    Time frame: 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.

  3. Level of literacy and numeracy

    Time frame: Re-enrollment visit, approximately 7 years post-intervention

  4. Presence of behavioral and emotional problems (socio-emotional development)

    Time frame: Re-enrollment visit, approximately 7 years post-intervention

Secondary outcomes

  1. Height-for-age

    Time frame: Re-enrollment visit, approximately 7 years post-intervention

  2. Weight-for-age

    Time frame: Re-enrollment visit, approximately 7 years post-intervention

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Grand Challenges Canada
  • Human Development Research Foundation, Pakistan

Registry information

Official study title

Perinatal Depression Treatment and Child Development: A Follow-Up of the Thinking Healthy Programme

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2013
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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