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

NCT04660253 | Completed DMC

• 1 other identifier: PILL-Dads-001
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in severity of symptoms measured using Hamilton Depression Rating Scale (Hamilton, 1960)

  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),

  Changes in severity of symptoms from baseline to 3rd month

Study Arms (1)

LTP Plus Dads

EXPERIMENTAL

Participants in this group will receive 10 sessions of LTP plus dads

Behavioral: LTP Plus Dads

Interventions

LTP Plus Dads BEHAVIORAL

LTP Plus Dads

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Depressed Fathers of children 0-30 months
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not willing to participate
• Out of trial catchment area

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Related Publications (1)

• 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.

  PMID: 33419080 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Long-Term Potentiation; amsonic acid

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Researchers doing outcome assessments
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 9, 2020
• Study Start: August 1, 2009
• Primary Completion: September 30, 2010
• Study Completion: September 30, 2010
• Last Updated: December 11, 2020

Record last verified: 2020-12