LTP Plus Dads-Partner Inclusive Intervention for Depressed Fathers in Pakistan

NCT05036720 | Completed DMC

• 1 other identifier: LTP+Dads TTS-1
• Study Type: interventional
• Target: 2,884
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to support and equip fathers and mothers with cognitive behavioral tools and knowledge about child development to be effective in their role as co-parent and partner, leading to improvement in paternal depression. Objectives:

• To evaluate the clinical and cost effectiveness of the Learning Through Play+ (LTP + ) intervention in reducing depression in fathers and mothers.
• To evaluate the effectiveness of the LTP+ intervention in improving child outcomes.
• Process evaluation and identifying challenges in transition to scale up of the intervention across Karachi, Pakistan from the perspective of fathers, mothers, and other stakeholders.

Conditions

Depression

Keywords

Parenting Intervention; Partner Inclusive; Low and middle-income country; Paternal Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1960)

  This is the most widely used clinician-rated depressive symptom scale, is validated in Urdu, and was used in our exploratory LTP Plus Dads trial. Higher score indicates more severe depression. Minimum score is 0 and maximum score is 68

  Changes from baseline to 4th and 6th month

Secondary Outcomes (23)

• Structured Clinical Interview for DSM-5 (SCID) (Spitzer, Williams, Gibbon, & First, 1992):

  Baseline

• Patient Health Questionnaire (PHQ-9) (Löwe, Kroenke, Herzog, & Gräfe, 2004):

  Changes from baseline to 4th and 6th month

• Generalised Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006):

  Changes from baseline to 4th and 6th month

• Parenting Stress Index (PSI -Short Form) (Haskett, Ahern, Ward, & Allaire, 2006):

  Changes from baseline to 4th and 6th month

• How Are You Feeling (Andrew Haig., 2008)

  Changes from baseline to 4th and 6th month

Other Outcomes (3)

• Kessler Psychological Distress Scale (K10) (Andrews & Slade, 2001):

  Changes from baseline to 4th month

• The Warwick-Edinburgh Mental Well-being Scale (WEMWBS):

  Changes from baseline to 4th month

• Weiman Occupational Stress Scale:(Weiman, 1978):

  Changes from baseline to 4th month

Study Arms (3)

LTP+Dads

EXPERIMENTAL

Participants in this arm will be offered the LTP+Dads intervention. The intervention will be delivered by trained Community Health Workers (CHWs). This will be co-facilitated by LTP+ master trainers.

Behavioral: LTP+Dads

Wait-list control:

OTHER

Participants in this arm will be offered the intervention once the LTP+ arm have completed their outcome assessment. For example, in each Union Council (UC) once the LTP+ arm has completed the intervention and 4th month outcome assessment the wait-list control group in the same UC will be offered the intervention.

Behavioral: LTP+Dads

Optional mothers component

OTHER

To facilitate changes in co-parenting and optimize impact on child development, the partners of fathers who participate will be offered optional LTP+ group sessions running parallel to LTP+Dads.

Behavioral: LTP+ Optional mother component

Interventions

LTP+Dads BEHAVIORAL

LTP+Dads is a 12 - session group integrated parenting intervention which includes a pictorial calendar, consisting of stages of child development from birth to 3 years. It includes parent-child play and other activities that promote parental involvement, learning, and attachment. The second component of the intervention is Cognitive Behaviour Therapy (CBT) adapted from the Jeanne Miranda manual (Group CBT for Depression) focusing on three areas: thoughts and your mood, activities and your mood, people interaction and your mood. The third component of intervention is content taken from Ed Bader's manual (Focus on Fathers) includes importance of fathers in child development, stress management at work and home, budgeting, anger management, conflict resolution and time management.

LTP+Dads; Wait-list control:

LTP+ Optional mother component BEHAVIORAL

LTP+ is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). The LTP+ is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.

Optional mothers component

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fathers with a child aged 0-30 months
• We will also include those fathers who have partners in their third trimester of the pregnancy.
• All participants (fathers) over 18 years.
• All fathers with a diagnosis of major depressive disorder (using the Structured Clinical Interview for DSM-5)
• Ability to understand and complete the baseline assessment.
• If the pandemic continues, having access to any of the video calling services such as Skype/Zoom will be required. Fathers who do not have access to digital platforms will be provided smartphones throughout the trial period.

You may not qualify if:

• Any acute severe mental/physical illness or intellectual disability, which prevents fathers from participation.
• Active suicidal ideation
• Temporary residency indicating that they may be unlikely to be available for follow up.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• Grand Challenges Canada: collaborator

Study Sites (1)

18 Towns

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Nasim Chaudhry, MD

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

• Muhammad Ishrat Husain, MD

  Centre for Addiction and Mental Health,Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 8, 2021
• Study Start: September 10, 2021
• Primary Completion: March 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

PA (1)