LTP Plus Dads-Partner Inclusive Intervention for Depressed Fathers in Pakistan (NCT05036720) | Clinical Trial Compass
CompletedNot Applicable
LTP Plus Dads-Partner Inclusive Intervention for Depressed Fathers in Pakistan
Pakistan2,884 participantsStarted 2021-09-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fathers with a child aged 0-30 months
* We will also include those fathers who have partners in their third trimester of the pregnancy.
* All participants (fathers) over 18 years.
* All fathers with a diagnosis of major depressive disorder (using the Structured Clinical Interview for DSM-5)
* Ability to understand and complete the baseline assessment.
* If the pandemic continues, having access to any of the video calling services such as Skype/Zoom will be required. Fathers who do not have access to digital platforms will be provided smartphones throughout the trial period.
Exclusion Criteria:
* Any acute severe mental/physical illness or intellectual disability, which prevents fathers from participation.
* Active suicidal ideation
* Temporary residency indicating that they may be unlikely to be available for follow up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1960)
Timeframe: Changes from baseline to 4th and 6th month