N/A
N=1,154
Thinking Healthy Program Peer Delivered Plus
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02658994 ↗Enrolled (actual)
1,154
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Depression (PHQ-9 Instrument) — 6.48; 5.84; 3.44 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thinking Healthy Program Peer Delivered Plus (Behavioral); Enhanced Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Human Development Research Foundation, Pakistan
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression (PHQ-9 Instrument) |
6.48; 5.84; 3.44 | — |
| PRIMARY Child Strength and Difficulties Questionnaire (SDQ) Total Difficulties (TD) Score |
14.72; 14.73; 13.69 | — |
| SECONDARY Disability (WHO Disability Assessment Schedule 2.0) |
16.11; 16.71; 5.61 | — |
| SECONDARY Infant Cognitive Development (Bayley Scales of Infant Development) |
9.98; 10.42; 10.41; 11.38; 11.42; 11.31 | — |
| SECONDARY Number of Participants With Depression (SCID Major Depressive Episode) |
48; 34; 42 | — |
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.
Eligibility Criteria
Inclusion Criteria
- currently enrolled in THPP trial
- married
- residing in study area for the long term
Exclusion Criteria
- Requiring immediate medical attention
- development of psychotic or manic episode
- broken mother-child dyad
Data sourced from ClinicalTrials.gov (NCT02658994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.