Thinking Healthy Program Peer Delivered Plus

NCT02658994 | Completed Results DMC

• 1 other identifier: THPPPlusChild001
• Study Type: interventional
• Target: 1,154
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Depression (PHQ-9 Instrument)

  The PHQ-9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. The results may be used to make a depression diagnosis according to the DSM-IV criteria. The PHQ-9 asks about patients experience in the last two weeks. Questions are about the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from "0" (not at all) to "3" (nearly every day). Scores range from 0-27, a total of 10 or above is suggestive of the presence of depression. PHQ-9 score Depression severity 0-4 minimal depression 5-9 mild depression 10-14 moderate depression 15-19 moderately severe depression 20+ severe depression

  36 months post-partum

• Child Strength and Difficulties Questionnaire (SDQ) Total Difficulties (TD) Score

  The SDQ is a parent-reported measure of 25 child attributes with five subscales of 5 items each; emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior. The TD score is calculated on the basis of four subscales (omitting prosocial behavior) with a score range of 0-40 points. The SDQ is widely used in low and middle-income countries and has been translated into Urdu. High SDQ scores are associated with a substantial increase in psychiatric risk. The TD score of our child participants is listed as a mean in the values below. TD score of 0-13 is considered "close to average, clinically significant problems in this area are unlikely," 14-16 is "slightly raised, which may reflect clinically significant problems," and 17-40 is "high, there is substantial risk of clinically significant problems in this area."

  36 months

Secondary Outcomes (3)

• Disability (WHO Disability Assessment Schedule 2.0)

  36 months post-partum

• Infant Cognitive Development (Bayley Scales of Infant Development)

  36 months

• Number of Participants With Depression (SCID Major Depressive Episode)

  36 months post-partum

Other Outcomes (1)

• Infant Physical Development [Z-scores (Based on WHO Criteria)]

  36 months

Study Arms (2)

THPP+

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Thinking Healthy Program Peer Delivered Plus BEHAVIORAL

THPP+

Enhanced Usual Care OTHER

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently enrolled in THPP trial
• married
• residing in study area for the long term

You may not qualify if:

• Requiring immediate medical attention
• development of psychotic or manic episode
• broken mother-child dyad

Sponsors & Collaborators

• Human Development Research Foundation, Pakistan: lead
• Duke University: collaborator
• Columbia University: collaborator
• University of Liverpool: collaborator
• University of Essex: collaborator

Study Sites (1)

Human Development Research Foundation

Islamabad, Pakistan

Location

Related Publications (5)

• LeMasters K, Bates LM, Chung EO, Gallis JA, Hagaman A, Scherer E, Sikander S, Staley BS, Zalla LC, Zivich PN, Maselko J. Adverse childhood experiences and depression among women in rural Pakistan. BMC Public Health. 2021 Feb 25;21(1):400. doi: 10.1186/s12889-021-10409-4.

  PMID: 33632175 DERIVED

• 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.

  PMID: 32828167 DERIVED

• 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.

  PMID: 31941468 DERIVED

• 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.

  PMID: 30819173 DERIVED

• 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.

  PMID: 27608926 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

The indicators of child socioemotional outcomes, although measured with validated and extensively used instruments, were mother reported, and, as such, susceptible to bias. However, if depression symptoms biased reporting, we would expect this to have affected the overall socioemotional domain, not just the hyperactivity or conduct problems reported in our study.

Results Point of Contact

• Title: Siham Sikander
• Organization: Human Development Research Foundation

sihamsikander@gmail.com

+923330590373

Study Officials

• Siham Sikander

  Human Development Research Foundation, Pakistan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 20, 2016
• Study Start: October 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Locations

PA (1)