Feasibility and Acceptability of Culturally Adapted Group Psychosocial Intervention for Depressed Fathers (LTP-Dads)
December 9, 2020 updated by: Pakistan Institute of Living and Learning
A Group Parenting Intervention for Depressed Fathers (LTP+ Dads): A Feasibility Study From Pakistan
The study is a feasibility trial with a pre and post-experiment design in Karachi, Pakistan's most populous city.
The intervention comprises of twelve sessions of learning through play (LTP) plus during the three month period.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Depressed fathers of children 0-30 months
- Given written informed consent
Exclusion Criteria:
- Not willing to participate
- Out of trial catchment area
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: LTP Plus Dads
Participants in this group will receive 10 sessions of LTP plus dads
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention feasibility
Time Frame: Baseline to 3rd month
|
Intervention feasibility tested by collating data on recruitment and retention rates.
The success criterion of feasibility is to recruit > 50% of eligible fathers
|
Baseline to 3rd month
|
|
Intervention acceptability
Time Frame: Baseline to 3rd month
|
Intervention acceptability assessed using data on attendance.
Criterion for acceptability is a mean attendance rate of >70% of at least 5 sessions.
|
Baseline to 3rd month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in severity of symptoms measured using Hamilton Depression Rating Scale (Hamilton, 1960)
Time Frame: Changes in severity of symptoms from baseline to 3rd month
|
It is the most widely used clinician-administered depression assessment on a 3-point or 5-point Likert-type scale.
Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale
|
Changes in severity of symptoms from baseline to 3rd month
|
|
Changes in severity of symptoms measured using Edinburgh Postnatal Depression Scale (EPDS; Cox et al. 1987),
Time Frame: Changes in severity of symptoms from baseline to 3rd month
|
A widely used 10-item measure of postnatal depression that has been used with fathers in the postnatal period.
The higher score shows high severity of depression.
|
Changes in severity of symptoms from baseline to 3rd month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2009
Primary Completion (ACTUAL)
September 30, 2010
Study Completion (ACTUAL)
September 30, 2010
Study Registration Dates
First Submitted
November 25, 2020
First Submitted That Met QC Criteria
December 6, 2020
First Posted (ACTUAL)
December 9, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 11, 2020
Last Update Submitted That Met QC Criteria
December 9, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PILL-Dads-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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