Perinatal Depression Treatment and Child Development

NCT01826903 | Completed

• 3 other identifiers: Pro00034166Saving Brains #0058ISRCTN65316374
• Study Type: observational
• Target: 964
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Cognitive Behavior Therapy; Child Development

Outcome Measures

Primary Outcomes (4)

• Estimate of general intelligence

  Re-enrollment visit, approximately 7 years post-intervention

• 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

• 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 Outcomes (2)

• Height-for-age

  Re-enrollment visit, approximately 7 years post-intervention

• Weight-for-age

  Re-enrollment visit, approximately 7 years post-intervention

Study Arms (3)

depressed mother/child dyad - intervention

depressed mother/child dyad - no intervention

non-depressed mother/child dyad

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study population includes children of women who participated in the Thinking Healthy Programme and children of women who were eligible for participation in the Thinking Healthy Programme but who screened negative for depression at the time.

You may qualify if:

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

You may not qualify if:

• developmental disability, visual or hearing impairment

Sponsors & Collaborators

• Duke University: lead
• Human Development Research Foundation, Pakistan: collaborator
• Grand Challenges Canada: collaborator

Study Sites (1)

Human Development Research Foundation

Islamabad, Pakistan

Location

Related 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.

  PMID: 18790313 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Joanna Maselko, ScD

  Duke University

  PRINCIPAL INVESTIGATOR

• Siham Sikander, PhD

  Human Development Research Foundation, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 9, 2013
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 20, 2015

Record last verified: 2015-04

Locations

PA (1)