CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,154 enrolled
Drug / intervention
Thinking Healthy Program Peer Delivered Plus +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02658994
NCT02658994N/ACompleted

Thinking Healthy Program - Peer Delivered in Pakistan - Child-Focused

Human Development Research Foundation, Pakistan·interventional·Posted Jan 20, 2016·Updated Apr 28, 2021

In Brief

A clinical study evaluating Thinking Healthy Program Peer Delivered Plus and Enhanced Usual Care for Depression. Completed, enrolled 1,154 participants across 1 site.

Detailed Summary

Background The negative effects of perinatal depression on mother and child start early and persist throughout the life-course. Given that 10-35% of children worldwide are exposed to perinatal depression in their first year of life, 16 mitigating this intergenerational risk is a global public health priority. However, there is a dearth of studies on whether a maternal depression intervention can have long-term benefits for either the mother or her child. This is a study of the effectiveness of an extended 36-month peer-delivered depression intervention, the Thinking Healthy Programme PLUS (THPP+) for women and their children in rural Pakistan. Study Design The THPP+ study aims to evaluate the effects of an extended 36-month perinatal depression intervention on mother and child outcomes using a cluster randomized controlled trial (c-RCT) design. The trial will recruit 560 pregnant women who screened positive for perinatal depression (PHQ-9 \>=10) from 40 village clusters, of which 20 clusters will receive the THPP+ intervention delivered by trained peers. These women will have already been participating in the trial of the shorter, 6 month long, version of the intervention. Women in the THPP+ intervention arm will receive bimonthly group-based sessions. Primary outcomes are 3-year maternal depression and 3-year child socio-emotional and cognitive development. All primary analyses will be intention-to-treat and will account for the clustered study design. Discussion This trial has the potential to further significantly our understanding of whether intervening on women's perinatal depression can mitigate the negative effects of maternal depression on 36-month child development.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesPakistan

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 20, 2016
Enrollment StartOct 1, 2014
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.5 years ago

Interventions

Thinking Healthy Program Peer Delivered Plusbehavioral

Enhanced Usual Careother