Clinical trial NCT02047357: Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity
Official title: Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity- A Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Keywords: Maternal depression
Mother
Child
LTP
Learning Through Play
Healthy thinking
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: The Hincks-Dellcrest Centre
First posted: 2014-01-28
Enrollment: 774
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Participants will be included in the study if they are:

  * 18 to 44 years old Mothers with children aged between 0-30 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

Primary outcomes:
measure: EPDS
timeFrame: Change from Baseline to 3 month
Secondary outcomes:
measure: Knowledge of Expectation and Child Development
timeFrame: Baseline, 3 months and 6 months
measure: Patient Health Questionnaire (PHQ) (Kroenke, Spitzer, Williams et al, 2001)
timeFrame: Baseline, 3 month and 6 month
measure: Generalized Anxiety Disorder (GAD) 7 (Spitzer, R. L., Kroenke, K., Williams, J. B., & Lowe, B. 2006)
timeFrame: Baseline, 3 month and 6 month
measure: Clinical Interview Schedule Revised (CISR)
timeFrame: Baseline, 3 month and 6 month
measure: Quality of life (EQ 5 D)
timeFrame: Baseline, 3 month and 6 month
Other outcomes:
measure: Cost effectiveness analysis
timeFrame: Baseline, 3 month and 6 month
Locations:
city: Karachi
country: Pakistan
facility: Community, Gadap
state: Sindh
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Batool Fatima
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hincks-Dellcrest Centre
name: Nancy Cohen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: