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Completed

NCT Number: NCT04660253

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not willing to participate
  • Out of trial catchment area

Treatment and study plan

LTP Plus Dads

Behavioral

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study title

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

Acronym: LTP-Dads

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2020
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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