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Clinical Trials/NCT03379077
NCT03379077
Completed
N/A

Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).

Pakistan Institute of Living and Learning1 site in 1 country1,006 target enrollmentDecember 20, 2017
ConditionsMothers

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mothers
Sponsor
Pakistan Institute of Living and Learning
Enrollment
1006
Locations
1
Primary Endpoint
Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The study has both quantitative and qualitative components.

The objective of the quantitative study is to:

Determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme.

The objective of the qualitative study is:

Process evaluation and finding out about implementation challenges (from the perspective of the mothers and the people delivering both the LTP plus and the supported implementation intervention).

Detailed Description

In Pakistan, the Learning through Play parenting program was tested initially through a cluster randomized study in a rural area of Pakistan. The results of this recently completed cluster RCT funded by the Grand Challenges Canada (GCC) showed that LTP Plus works and benefits both the mother and the child. More specifically, the results indicate a significant reduction in maternal depression. Purpose of this cluster RCT is to determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme. This is an implementation trial comparing two ways of introducing LTP plus. A Cluster RCT of culturally adapted intervention LTP Plus will be conducted in the villages of Gadap town, Karachi, Pakistan. Total 60 villages will be randomized in two groups LTP plus and LTP plus supported implementation. Each cluster will be made of up to 15 mothers. Participants will be screened using eligibility checklist. Assessments will be done at baseline and after completion of intervention (3-month). All follow ups will be done by independent RAs, not involved in delivering intervention sessions.

Registry
clinicaltrials.gov
Start Date
December 20, 2017
End Date
February 28, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participants will be included in the study if they are:
  • 18 to 44 years old mothers with children aged between 0-33 months, resident in the trial site catchments area, who are able to complete assessments

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)

Time Frame: Change from baseline at 3rd Month

This scale will be used to measure child development. Parents will report on their child's communication,gross motor, fine motor, problem solving and personal-social development.

Study Sites (1)

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