NCT02047357

Brief Summary

To test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lady health workers with minimal training in low resource countries such as Pakistan

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
774

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

January 21, 2014

Last Update Submit

October 26, 2017

Conditions

Maternal Depression

Keywords

Maternal depressionMotherChildLTPLearning Through PlayHealthy thinking

Outcome Measures

Primary Outcomes (1)

  • EPDS

    The EPDS is a self-report questionnaire composed of ten items scored on a four-point scale (0-3) designed to assess pregnancy and postpartum depression Cox et al. (1987).

    Change from Baseline to 3 month

Secondary Outcomes (5)

  • Knowledge of Expectation and Child Development

    Baseline, 3 months and 6 months

  • Patient Health Questionnaire (PHQ) (Kroenke, Spitzer, Williams et al, 2001)

    Baseline, 3 month and 6 month

  • Generalized Anxiety Disorder (GAD) 7 (Spitzer, R. L., Kroenke, K., Williams, J. B., & Lowe, B. 2006)

    Baseline, 3 month and 6 month

  • Clinical Interview Schedule Revised (CISR)

    Baseline, 3 month and 6 month

  • Quality of life (EQ 5 D)

    Baseline, 3 month and 6 month

Other Outcomes (1)

  • Cost effectiveness analysis

    Baseline, 3 month and 6 month

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Learning Through Play Plus

Other: Learning Through Play Plus

Control

NO INTERVENTION

This arm will receive no intervention

Interventions

Learning Through Play PlusOTHER

Learning Through Play (LTP) Plus is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.

Also known as: Psycho social intervention
Intervention Arm

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants will be included in the study if they are:
  • to 44 years old Mothers with children aged between 0-30 months
  • Resident in the trial site catchments area
  • Ability to complete a baseline assessment

You may not qualify if:

  • Participants will be excluded from the study if they have:
  • A medical disorder that would prevent participation in clinical trial.
  • Temporary resident unlikely to be available for follow up.
  • Active suicidal ideation or any other severe or physical mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community, Gadap

Karachi, Sindh, 75780, Pakistan

Location

Related Publications (1)

  • Ashraf T, Alvi MH, Ullah A, Kiran T, Gumber A, Sikander S, Chaudhry N, Chaudhry IB, Husain N. Economic evaluation of Learning Through Play Plus in comparison to usual care for depressed mothers alongside a randomised controlled trial. BMC Health Serv Res. 2026 Feb 4. doi: 10.1186/s12913-026-14113-0. Online ahead of print.

    PMID: 41639802DERIVED

Related Links

Study Officials

  • Batool Fatima

    Pakistan Institute of Living and Learning

    PRINCIPAL INVESTIGATOR

  • Nancy Cohen, Ph.D

    The Hincks-Dellcrest Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 28, 2014

Study Start

December 1, 2013

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

PA(1)