Feasibility and Acceptability of Culturally Adapted Group Psychosocial Intervention for Depressed Fathers

Study Overview
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Brief Summary
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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.

Official Title
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A Group Parenting Intervention for Depressed Fathers (LTP+ Dads): A Feasibility Study From Pakistan

Conditions
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Depression

Intervention / Treatment
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* Behavioral: LTP Plus Dads


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Depressed fathers of children 0-30 months Given written informed consent Exclusion Criteria: Not willing to participate Out of trial catchment area

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This integrated intervention is called LTP Plus Dads consisting of 10 group sessions delivered weekly by trained professionals who received weekly supervision by LTP Plus master trainers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTP Plus Dads<br>Participants in this group will receive 10 sessions of LTP plus dads | Behavioral: LTP Plus Dads<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention feasibility | 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 | 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) | 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), | 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 |