Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity

NCT ID: NCT02047357

Last Updated: 2017-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 774 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Maternal Depression

Keywords

Maternal depression; Mother; Child; LTP; Learning Through Play; Healthy thinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm

Learning Through Play Plus

Group Type: EXPERIMENTAL

Learning Through Play Plus

Intervention Type: OTHER

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.

Control

This arm will receive no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Learning Through Play Plus

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.

Intervention Type: OTHER

Other Intervention Names

Psycho social intervention

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Grand Challenges Canada

OTHER

Sponsor Role: collaborator

The Hincks-Dellcrest Centre

OTHER

Sponsor Role: collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Batool Fatima

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Nancy Cohen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Hincks-Dellcrest Centre

Locations

Community, Gadap

Karachi, Sindh, Pakistan

Countries

Pakistan

Related Links

http://pill.org.pk

Pakistan Institute of learning and living

Other Identifiers

LTP-PLUS 001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ROS-PILL-001

Identifier Type: -

Identifier Source: org_study_id