Clinical trial NCT01826903: Perinatal Depression Treatment and Child Development
Official title: Perinatal Depression Treatment and Child Development: A Follow-Up of the Thinking Healthy Programme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Depression
Cognitive Behavior Therapy
Child Development
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Human Development Research Foundation, Pakistan
name: Grand Challenges Canada
First posted: 2013-04-09
Enrollment: 964
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* developmental disability, visual or hearing impairment

Primary outcomes:
measure: Estimate of general intelligence
timeFrame: Re-enrollment visit, approximately 7 years post-intervention
measure: Measures of executive functions
timeFrame: Re-enrollment visit, approximately 7 years post-intervention
measure: Level of literacy and numeracy
timeFrame: Re-enrollment visit, approximately 7 years post-intervention
measure: Presence of behavioral and emotional problems (socio-emotional development)
timeFrame: Re-enrollment visit, approximately 7 years post-intervention
Secondary outcomes:
measure: Height-for-age
timeFrame: Re-enrollment visit, approximately 7 years post-intervention
measure: Weight-for-age
timeFrame: Re-enrollment visit, approximately 7 years post-intervention
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Human Development Research Foundation
Study officials:
affiliation: Duke University
name: Joanna Maselko, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Human Development Research Foundation, Pakistan
name: Siham Sikander, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.