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

Depression Clinical Trial

— LTP-Dads  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660253
• Other study ID #: PILL-Dads-001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2009
• Est. completion date: September 30, 2010

Study information

• Verified date: December 2020
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 30, 2010
• Est. primary completion date: September 30, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Depressed fathers of children 0-30 months
• Given written informed consent

Exclusion Criteria:

• Not willing to participate
• Out of trial catchment area

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• LTP Plus Dads

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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