Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy for Mothers of Young Children (ROSHNI-2)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).

Conditions
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Mothers

Intervention / Treatment
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* Behavioral: LTP Plus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTP Plus Supported Implementation<br>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 | Behavioral: LTP Plus<br>* LTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). The 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.<br>* Other names: Psycho-social Intervention;|
| Active Comparator: LTP Plus<br>Participants in LTP Plus arm will receive LTP plus intervention by trained LHWs of Health and Nutrition Development Society (HANDS). | Behavioral: LTP Plus<br>* LTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). The 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.<br>* Other names: Psycho-social Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009) | 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. | Change from baseline at 3rd Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mothers, young children, Implementation, Learning through play Plus, Cognitive Behavior Therapy