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

NCT ID: NCT05036720

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2884 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2023-12-30

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.

Detailed Description

Parental depression is the leading cause of disability worldwide and low- and middle-income countries (LMIC) carry over 80% of this disease burden. Furthermore, parenting is a likely key mechanism for the intergenerational transmission of mental health risk particularly in LMICs as poverty undermines nurturing care in favour of survival. In LMICs, three quarters of young children experience physical discipline and harsh, coercive parenting is widespread. These issues are compounded by a lack of child and family policies. Attempts have been made to address maternal postnatal depression in LMICs, adopting parenting interventions mainly developed in high income countries (HIC) with improvements found in the home environment and maternal knowledge. The lack of focus on fathers may undermine intervention efforts to address depression in the current situation with Covid 19. Recognising the father as a key influencer in the family offers an alternative, systemic approach to breaking the intergenerational cycle of depression and fear during this pandemic, as well as directly addressing the father's own mental health. By alleviating paternal depression in the child's early years, a father is in a unique position to influence maternal wellbeing and his child's positive development. The novel aspect of the proposed project is the delivery of an innovative psychosocial intervention to depressed fathers. The fathers will receive a culturally adapted manual assisted group parenting intervention that incorporates a psychoeducational parenting programme i.e Learning Through Play (LTP) for fathers integrated with group cognitive behaviour therapy (CBT). Their partners (mothers) will be offered optional LTP+ developed for mothers. The study will be conducted in 18 towns across the city of Karachi, the largest city in Pakistan with a population of approximately 23 million. with Aa total of 2880 depressed fathers and their partners will participate in the study. In addition, a total of 4000 Community health workers(CHWs) will be trained in the LTP+ training program across Pakistan

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

LTP+Dads

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.

Group Type: EXPERIMENTAL

LTP+Dads

Intervention Type: 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.

Wait-list control:

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.

Group Type: OTHER

LTP+Dads

Intervention Type: 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.

Optional mothers component

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.

Group Type: OTHER

LTP+ Optional mother component

Intervention Type: 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.

Interventions

LTP+Dads

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.

Intervention Type: BEHAVIORAL

LTP+ Optional mother component

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grand Challenges Canada

OTHER

Sponsor Role: collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nasim Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Muhammad Ishrat Husain, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health,Canada

Locations

18 Towns

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

LTP+Dads TTS-1

Identifier Type: -

Identifier Source: org_study_id