Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05036720
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2021-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LTP Plus Dads-Partner Inclusive Intervention for Depressed Fathers in Pakistan
Sponsor:
Pakistan Institute of Living and Learning
Organization:
Study Overview
Official Title:
Partner Inclusive Culturally Adapted Low-cost Group Parenting Programme for Depressed Fathers: A Cluster, Randomized Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTP+Dads
Brief Summary:
The aim of this study is to support and equip fathers and mothers with cognitive behavioral tools and knowledge about child development to be effective in their role as co-parent and partner, leading to improvement in paternal depression.
Objectives:
* To evaluate the clinical and cost effectiveness of the Learning Through Play+ (LTP + ) intervention in reducing depression in fathers and mothers.
* To evaluate the effectiveness of the LTP+ intervention in improving child outcomes.
* Process evaluation and identifying challenges in transition to scale up of the intervention across Karachi, Pakistan from the perspective of fathers, mothers, and other stakeholders.
Objectives:
* To evaluate the clinical and cost effectiveness of the Learning Through Play+ (LTP + ) intervention in reducing depression in fathers and mothers.
* To evaluate the effectiveness of the LTP+ intervention in improving child outcomes.
* Process evaluation and identifying challenges in transition to scale up of the intervention across Karachi, Pakistan from the perspective of fathers, mothers, and other stakeholders.
Detailed Description:
Parental depression is the leading cause of disability worldwide and low- and middle-income countries (LMIC) carry over 80% of this disease burden. Furthermore, parenting is a likely key mechanism for the intergenerational transmission of mental health risk particularly in LMICs as poverty undermines nurturing care in favour of survival. In LMICs, three quarters of young children experience physical discipline and harsh, coercive parenting is widespread. These issues are compounded by a lack of child and family policies. Attempts have been made to address maternal postnatal depression in LMICs, adopting parenting interventions mainly developed in high income countries (HIC) with improvements found in the home environment and maternal knowledge. The lack of focus on fathers may undermine intervention efforts to address depression in the current situation with Covid 19. Recognising the father as a key influencer in the family offers an alternative, systemic approach to breaking the intergenerational cycle of depression and fear during this pandemic, as well as directly addressing the father's own mental health. By alleviating paternal depression in the child's early years, a father is in a unique position to influence maternal wellbeing and his child's positive development. The novel aspect of the proposed project is the delivery of an innovative psychosocial intervention to depressed fathers. The fathers will receive a culturally adapted manual assisted group parenting intervention that incorporates a psychoeducational parenting programme i.e Learning Through Play (LTP) for fathers integrated with group cognitive behaviour therapy (CBT). Their partners (mothers) will be offered optional LTP+ developed for mothers. The study will be conducted in 18 towns across the city of Karachi, the largest city in Pakistan with a population of approximately 23 million. with Aa total of 2880 depressed fathers and their partners will participate in the study. In addition, a total of 4000 Community health workers(CHWs) will be trained in the LTP+ training program across Pakistan
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: