Feasibility and Acceptability of Culturally Adapted Group Psychosocial Intervention for Depressed Fathers (LTP-Dads)

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

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: LTP Plus Dads

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LTP Plus Dads; Participants in this group will receive 10 sessions of LTP plus dads	Behavioral: LTP Plus Dads

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning

Publications and helpful links

General Publications

• Husain MI, Chaudhry IB, Khoso AB, Wan MW, Kiran T, Shiri T, Chaudhry N, Mehmood N, Jafri SF, Naeem F, Husain N. A Group Parenting Intervention for Depressed Fathers (LTP + Dads): A Feasibility Study from Pakistan. Children (Basel). 2021 Jan 6;8(1):26. doi: 10.3390/children8010026.

Study record dates

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: Behavioral Symptoms; Depression
• 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