Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity- A Cluster-Randomized Controlled Trial
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
Learning Through Play Plus
Intervention: Learning Through Play Plus (Other)
Control
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)
