Clinical trial NCT05036720: LTP Plus Dads-Partner Inclusive Intervention for Depressed Fathers in Pakistan
Official title: Partner Inclusive Culturally Adapted Low-cost Group Parenting Programme for Depressed Fathers: A Cluster, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Parenting Intervention
Partner Inclusive
Low and middle-income country
Paternal Depression
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
First posted: 2021-09-08
Enrollment: 2884
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1960)
timeFrame: Changes from baseline to 4th and 6th month
Secondary outcomes:
measure: Structured Clinical Interview for DSM-5 (SCID) (Spitzer, Williams, Gibbon, & First, 1992):
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9) (Löwe, Kroenke, Herzog, & Gräfe, 2004):
timeFrame: Changes from baseline to 4th and 6th month
measure: Generalised Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006):
timeFrame: Changes from baseline to 4th and 6th month
measure: Parenting Stress Index (PSI -Short Form) (Haskett, Ahern, Ward, & Allaire, 2006):
timeFrame: Changes from baseline to 4th and 6th month
measure: How Are You Feeling (Andrew Haig., 2008)
timeFrame: Changes from baseline to 4th and 6th month
measure: Knowledge, Attitudes and Practices (KAP) (Rahman et al., 2009):
timeFrame: Changes from baseline to 4th and 6th month
measure: Hurt, Insulted, Threatened with Harm and Screamed (HITS) (Sherin, Sinacore, Li, Zitter, & Shakil, 1998)
timeFrame: Changes from baseline to 4th and 6th month
measure: Euro-Qol Five- Dimensions (EQ-5D-5L) (Herdman et al., 2011):
timeFrame: Changes from baseline to 4th and 6th month
measure: Client Service Receipt Inventory (CSRI) (Beecham & Knapp, 1995):
timeFrame: Changes from baseline to 4th and 6th month
measure: Dyadic Adjustment Scale(DAS):(Spanier, 1976)
timeFrame: Changes from baseline to 4th and 6th month
measure: The Prodromal Questionnaire-(PQ-16) (Loewy, Bearden, Johnson, Raine, & Cannon, 2005):
timeFrame: Changes from baseline to 4th and 6th month
measure: World Health Organization Disability Assessment Schedule 2.0 (World Health Organization, 2000)
timeFrame: Changes from baseline to 4th and 6th month
measure: Problem Solving Inventory-(PSI) (Heppner, 1988):
timeFrame: Changes from baseline to 4th and 6th month
measure: The General Self-Efficacy Scale (GSES) (Schwarzer & Jerusalem, 2010):
timeFrame: Baseline, 4th and 6th month
measure: The Postpartum Bonding Questionnaire (PBQ) (Brockington, Fraser, & Wilson, 2006):
timeFrame: Changes from baseline to 4th and 6th month
measure: Assessment of the growth and development of children: Weight
timeFrame: Change in weight from Baseline and 6th month
measure: Assessment of the growth and development of children: Height
timeFrame: change in height from Baseline and 6th month
measure: Assessment of the growth and development of children: Head circumference
timeFrame: change in head circumference measurement from Baseline and 6th month
measure: Ages and Stages Questionnaire (ASQ) and ASQ Socio-emotional Scales (ASQ: SE) (Squires et al., 2015),
timeFrame: Changes from baseline to 4th and 6th month
measure: Manchester Assessment of Caregiver-Infant Interaction (MACI) (Wan, Brooks, Green, Abel, & Elmadih, 2017):
timeFrame: Baseline and 4th month
measure: Bayley Scales of Infant Development (Bayley, 1993):
timeFrame: Baseline and 6th month
measure: Home Observation for Measurement of the Environment (HOME) (Caldwell & Bradley, 1984):
timeFrame: Changes from baseline to 4th and 6th month
measure: World Health Organisation Quality of Life (WHOQOL-BREF) (WHO, 1997)
timeFrame: Changes from baseline to 4th and 6th month
Other outcomes:
measure: Kessler Psychological Distress Scale (K10) (Andrews & Slade, 2001):
timeFrame: Changes from baseline to 4th month
measure: The Warwick-Edinburgh Mental Well-being Scale (WEMWBS):
timeFrame: Changes from baseline to 4th month
measure: Weiman Occupational Stress Scale:(Weiman, 1978):
timeFrame: Changes from baseline to 4th month
Locations:
city: Karachi
country: Pakistan
facility: 18 Towns
state: Sindh
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health,Canada
name: Muhammad Ishrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
References: