Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,006
- Locations
- 1
- Primary Endpoint
- Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
researchers doing outcome assessment will be kept blind on both implementation groups
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
LTP Plus Supported Implementation
LTP Plus Supported Implementation group participants will receive intervention by trained LHWs of HANDS, co-facilitated and supervised by senior trained PILL researchers, expert in delivering LTP plus intervention
Intervention: LTP Plus (Behavioral)
LTP Plus
Participants in LTP Plus arm will receive LTP plus intervention by trained LHWs of Health and Nutrition Development Society (HANDS).
Intervention: LTP Plus (Behavioral)
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.
Secondary Outcomes
No secondary outcomes reported