Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thinking Healthy Program Peer Delivered Plus (THPP+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658994
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
Duke University
Columbia University
University of Liverpool
University of Essex
Information provided by (Responsible Party):
Human Development Research Foundation, Pakistan

Brief 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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Thinking Healthy Program Peer Delivered Plus Other: Enhanced Usual Care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: THPP+
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



Primary Outcome Measures :
  1. Depression (PHQ-9 instrument) [ Time Frame: 36 months post-partum ]
    we will use the PHQ-9 instrument

  2. Infant socioemotional development (Strengths and Difficulties Questionnaire) [ Time Frame: 36 months ]
    Total Difficulties score from the Strengths and Difficulties Questionnaire


Secondary Outcome Measures :
  1. Disability (WHO Disability Assessment Schedule) [ Time Frame: 36 months post-partum ]
    WHO Disability Assessment Schedule

  2. Infant cognitive development (Bayley Scales of Infant Development) [ Time Frame: 36 months ]
    Bayley Scales of Infant Development

  3. Depression (SCID Major Depressive Episode) [ Time Frame: 36 months post-partum ]
    Structured Clinical Interview for DSM-IV Diagnosis/Major Depressive Episode


Other Outcome Measures:
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Pakistan
Human Development Research Foundation
Islamabad, Pakistan
Sponsors and Collaborators
Human Development Research Foundation, Pakistan
Duke University
Columbia University
University of Liverpool
University of Essex
Investigators
Layout table for investigator information
Principal Investigator: Siham Sikander Human Development Research Foundation, Pakistan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Human Development Research Foundation, Pakistan
ClinicalTrials.gov Identifier: NCT02658994    
Other Study ID Numbers: THPPPlusChild001
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms