Thinking Healthy Program Peer Delivered Plus (THPP+)

• ClinicalTrials.gov Identifier: NCT02658994
• Recruitment Status: Active, not recruiting
• First Posted: January 20, 2016
• Last Update Posted: June 19, 2019
• Sponsor: Human Development Research Foundation, Pakistan
• Collaborators: Duke University; Columbia University; University of Liverpool; University of Essex
• Information provided by (Responsible Party): Human Development Research Foundation, Pakistan

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Siham Sikander; Human Development Research Foundation, Pakistan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maselko J, Sikander S, Turner EL, Bates LM, Ahmad I, Atif N, Baranov V, Bhalotra S, Bibi A, Bibi T, Bilal S, Biroli P, Chung E, Gallis JA, Hagaman A, Jamil A, LeMasters K, O'Donnell K, Scherer E, Sharif M, Waqas A, Zaidi A, Zulfiqar S, Rahman A. Effectiveness of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal: a cluster randomised trial in Pakistan. Lancet Psychiatry. 2020 Sep;7(9):775-787. doi: 10.1016/S2215-0366(20)30258-3. Erratum in: Lancet Psychiatry. 2020 Nov 24;:.

LeMasters K, Andrabi N, Zalla L, Hagaman A, Chung EO, Gallis JA, Turner EL, Bhalotra S, Sikander S, Maselko J. Maternal depression in rural Pakistan: the protective associations with cultural postpartum practices. BMC Public Health. 2020 Jan 15;20(1):68. doi: 10.1186/s12889-020-8176-0.

Scherer E, Hagaman A, Chung E, Rahman A, O'Donnell K, Maselko J. The relationship between responsive caregiving and child outcomes: evidence from direct observations of mother-child dyads in Pakistan. BMC Public Health. 2019 Feb 28;19(1):252. doi: 10.1186/s12889-019-6571-1.

Turner EL, Sikander S, Bangash O, Zaidi A, Bates L, Gallis J, Ganga N, O'Donnell K, Rahman A, Maselko J. The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for a three-year cluster randomized controlled trial. Trials. 2016 Sep 8;17(1):442. doi: 10.1186/s13063-016-1530-y. Erratum in: Trials. 2017 Feb 16;18(1):74.

• Responsible Party: Human Development Research Foundation, Pakistan
• ClinicalTrials.gov Identifier: NCT02658994
• Other Study ID Numbers: THPPPlusChild001
• First Posted: January 20, 2016
• Last Update Posted: June 19, 2019
• Last Verified: June 2019

Additional relevant MeSH terms:

Depression; Behavioral Symptoms