Thinking Healthy Program Peer Delivered Plus (THPP+)
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|ClinicalTrials.gov Identifier: NCT02658994|
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : June 19, 2019
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Thinking Healthy Program Peer Delivered Plus Other: Enhanced Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Thinking Healthy Program - Peer Delivered in Pakistan - Child-Focused|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
As part of THPP+, the intervention will continue from the 6th month postnatal through 36 months postnatal and so will consist of an additional 30 months of lower intensity services that are unique to THPP+. The THPP+ will also include additional group sessions to be held every other month for a total of 18 over the intervention duration. The content will be a continuation of the previous THPP sessions with continuing emphasis on self-care as well as the baby's health and development.
Behavioral: Thinking Healthy Program Peer Delivered Plus
Active Comparator: Enhanced Usual Care
Women in the control clusters who were depressed prenatally have been receiving Enhanced Usual Care (EUC). At the time of the screening, women, their Lady Health Workers, and their local primary health care facility were informed of the diagnosis, and women were given an information sheet about depression and how to access care. There are no new EUC protocols put in place post-partum as part of the THPP+.
Other: Enhanced Usual Care
- Depression (PHQ-9 instrument) [ Time Frame: 36 months post-partum ]we will use the PHQ-9 instrument
- Infant socioemotional development (Strengths and Difficulties Questionnaire) [ Time Frame: 36 months ]Total Difficulties score from the Strengths and Difficulties Questionnaire
- Disability (WHO Disability Assessment Schedule) [ Time Frame: 36 months post-partum ]WHO Disability Assessment Schedule
- Infant cognitive development (Bayley Scales of Infant Development) [ Time Frame: 36 months ]Bayley Scales of Infant Development
- Depression (SCID Major Depressive Episode) [ Time Frame: 36 months post-partum ]Structured Clinical Interview for DSM-IV Diagnosis/Major Depressive Episode
- Infant physical development [Z-scores (based on WHO criteria)] [ Time Frame: 36 months ]weight-for-age and height-for-age Z-scores (based on WHO criteria)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658994
|Human Development Research Foundation|
|Principal Investigator:||Siham Sikander||Human Development Research Foundation, Pakistan|