Trials / Completed
CompletedNCT03379077
Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy for Mothers of Young Children (ROSHNI-2)
Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,006 (actual)
- Sponsor
- Pakistan Institute of Living and Learning · Academic / Other
- Sex
- Female
- Age
- 18 Years – 44 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | LTP Plus | 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. |
Timeline
- Start date
- 2017-12-20
- Primary completion
- 2019-02-28
- Completion
- 2019-02-28
- First posted
- 2017-12-20
- Last updated
- 2022-04-29
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT03379077. Inclusion in this directory is not an endorsement.