Perinatal Depression Treatment and Child Development

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826903
• Other study ID #: Pro00034166
• Secondary ID: Saving Brains #0
• Status: Completed
• Phase: N/A
• First received: March 26, 2013
• Last updated: April 17, 2015
• Start date: July 2012
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 964
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 7 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• developmental disability, visual or hearing impairment

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder

Locations

Country	Name	City	State
Pakistan	Human Development Research Foundation	Islamabad

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Grand Challenges Canada, Human Development Research Foundation, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate of general intelligence		Re-enrollment visit, approximately 7 years post-intervention	No
Primary	Measures of executive functions	Working memory, cognitive flexibility, inhibitory control, and sustained attention will be measured by standard tests of cognitive functioning.	Re-enrollment visit, approximately 7 years post-intervention	No
Primary	Level of literacy and numeracy		Re-enrollment visit, approximately 7 years post-intervention	No
Primary	Presence of behavioral and emotional problems (socio-emotional development)		Re-enrollment visit, approximately 7 years post-intervention	No
Secondary	Height-for-age		Re-enrollment visit, approximately 7 years post-intervention	No
Secondary	Weight-for-age		Re-enrollment visit, approximately 7 years post-intervention	No

External Links

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