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Clinical Trials/NCT02047357
NCT02047357CompletedNot Applicable

Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity- A Cluster-Randomized Controlled Trial

Pakistan Institute of Living and Learning2 sites in 1 country774 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
774
Locations
2
Primary Endpoint
EPDS

Study Overview

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

Detailed Description

Specific challenges: In Pakistan rates of depression particularly in women are high, as well as other risks to the growth and development of young children and child mortality. Numerous studies provide compelling evidence that maternal depression not only affects mothers but is also associated with long term emotional, cognitive and behavioural problems in children. Depressed mothers are unable to provide primary care necessary for growth of their children during the first 3-years of life, a critical period for child development. Disability due to depressive symptoms (such as fatigue, poor concentration, loss of interest) is likely to affect child-care abilities directly, while impaired social functioning is likely to have indirect consequences through lack of support in childcare. Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There is now evidence from some low income countries that effectively delivered participatory group interventions are cost effective intervention for improving maternal and child health. The Community-Based participatory Intervention LTP Plus has been designed to address maternal depression and a parenting program of child psychosocial development through mother-infant play providing stimulation, and support for exploration and autonomy for the infant.The proposed study will test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lay health workers with minimal training in low resource countries such as Pakistan.

Project Impact: LTP Plus is proposed as a low cost intervention to improve maternal mental and physical health, reduce infant and children under five years' morbidity and mortality, and promote healthy child development. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 44 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants will be included in the study if they are:
  • 18 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

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

Arms & Interventions

Intervention Arm

Experimental

Learning Through Play Plus

Intervention: Learning Through Play Plus (Other)

Control

No Intervention

This arm will receive no intervention

Outcomes

Primary Outcomes

EPDS

Time Frame: Change from Baseline to 3 month

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).

Secondary Outcomes

  • Clinical Interview Schedule Revised (CISR)(Baseline, 3 month and 6 month)
  • Quality of life (EQ 5 D)(Baseline, 3 month and 6 month)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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