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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: LTP Plus Dads

• Registration Number: NCT04660253
• Lead Sponsor: Pakistan Institute of Living and Learning

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-01
• Primary Completion: 2010-09-30
• Study Completion: 2010-09-30
• Study First Submitted: 2020-11-25
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-09
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LTP Plus Dads	LTP Plus Dads	Participants in this group will receive 10 sessions of LTP plus dads

Primary Outcome Measures

Name	Time	Method
Intervention feasibility	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
Intervention acceptability	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.

Secondary Outcome Measures

Name	Time	Method
Change in severity of symptoms measured using Hamilton Depression Rating Scale (Hamilton, 1960)	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 measured using Edinburgh Postnatal Depression Scale (EPDS; Cox et al. 1987),	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.