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

Depression Clinical Trial

— LTP+Dads  

Official title:

Partner Inclusive Culturally Adapted Low-cost Group Parenting Programme for Depressed Fathers: A Cluster, Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05036720
• Other study ID #: LTP+Dads TTS-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2884
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Pakistan	18 Towns	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	Grand Challenges Canada

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kessler Psychological Distress Scale (K10) (Andrews & Slade, 2001):	It is used to measure psychological distress. It's a 10-item scale measuring emotional states with a 5-level response scale. We will use this measure with community health workers before and after training. Higher score indicates more severe stress, ranging from 10- 50.	Changes from baseline to 4th month
Other	The Warwick-Edinburgh Mental Well-being Scale (WEMWBS):	we will be using the Short Warwick Edinburgh Mental Wellbeing 7 items Scale (SWEMWBS) (Tennant et al., 2007), where a higher score indicates greater psychological wellbeing. Administration time: 3-6 minutes. We will use this measure with community health workers before and after training.	Changes from baseline to 4th month
Other	Weiman Occupational Stress Scale:(Weiman, 1978):	Job related stress will be measured using Weiman Occupational Stress scale. We will use this measure with community health workers before and after training.	Changes from baseline to 4th month
Primary	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	Structured Clinical Interview for DSM-5 (SCID) (Spitzer, Williams, Gibbon, & First, 1992):	The SCID is a semi-structured diagnostic interview which has been widely used in cross-national epidemiological and treatment studies (Weissman et al., 1996). The interview consists of standardized diagnostic questions arranged in modules corresponding to each DSM-V disorder. This interview will be conducted by trained psychologists.	Baseline
Secondary	Patient Health Questionnaire (PHQ-9) (Löwe, Kroenke, Herzog, & Gräfe, 2004):	The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Higher score indicates more severe depression. Scores ranging from 1-4 Minimal depression, 5-9 Mild depression,10-14 Moderate depression,15-19 Moderately severe depression, 20-27 Severe depression.	Changes from baseline to 4th and 6th month
Secondary	Generalised Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006):	A 7-item scale measuring generalised anxiety. GAD-7 total score for the seven items ranges from 0 to 21. Higher score indicates more severe anxiety.	Changes from baseline to 4th and 6th month
Secondary	Parenting Stress Index (PSI -Short Form) (Haskett, Ahern, Ward, & Allaire, 2006):	A 36-item perceived stress measure in 3 subscales, parenting distress, difficult child characteristics, and dysfunctional parent-child interaction. A Total score is calculated by summing the three subscales scores, ranging from 36 to 180. Scores of 90 or above may indicate a clinical level of stress. Higher score indicates more severe parenting stress.	Changes from baseline to 4th and 6th month
Secondary	How Are You Feeling (Andrew Haig., 2008)	This picture booklet can help the early detection of mood disturbance in pregnancy and/or following childbirth. The booklet can be used by a verity of health workers or support workers. It is designed to assess the feelings today and in the past few days and to talk about moods, emotions and general health." Higher score indicates more severe depression	Changes from baseline to 4th and 6th month
Secondary	Knowledge, Attitudes and Practices (KAP) (Rahman et al., 2009):	A 25 -item questionnaire of paternal knowledge and expectations for child development in the first three years. Higher score indicate (ranging from 0 to 25) better knowledge about child development.	Changes from baseline to 4th and 6th month
Secondary	Hurt, Insulted, Threatened with Harm and Screamed (HITS) (Sherin, Sinacore, Li, Zitter, & Shakil, 1998)	A 4-item intimate partner violence screener producing a score of 4-20. Higher score indicates more severe level of violence	Changes from baseline to 4th and 6th month
Secondary	Euro-Qol Five- Dimensions (EQ-5D-5L) (Herdman et al., 2011):	Health-related quality of life as measured for mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.	Changes from baseline to 4th and 6th month
Secondary	Client Service Receipt Inventory (CSRI) (Beecham & Knapp, 1995):	It is used to collect information on the whole range of services and supports study participants may use. This data can be used for a wide range of applications, including estimating the costs of service receipt.	Changes from baseline to 4th and 6th month
Secondary	Dyadic Adjustment Scale(DAS):(Spanier, 1976)	DAS is a 32 items self-report questionnaire, to measure couple satisfaction and to assess how each partner perceives his/her relationship. The scale has good psychometric properties (Graham, Liu, & Jeziorski, 2006) and has also been used with depressed mothers (Wolman, Chalmers, Hofmeyr, & Nikodem, 1993). The resultant score ranges from 0 to 151, with higher scores indicating a more positive dyadic adjustment and a lower level of distress.	Changes from baseline to 4th and 6th month
Secondary	The Prodromal Questionnaire-(PQ-16) (Loewy, Bearden, Johnson, Raine, & Cannon, 2005):	A brief self-report screening questionnaire that assesses the presence of attenuated psychotic symptoms, the PQ-16 is a reliable measure and correlates well with the CAARMS. The scale has been used in a previous study in Pakistan (Qurashi et al., 2017). Higher score (range 0-16) indicates more probability of having psychosis.	Changes from baseline to 4th and 6th month
Secondary	World Health Organization Disability Assessment Schedule 2.0 (World Health Organization, 2000)	The adult self-administered version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item measure that assesses disability in adults age 18 years and older. It assesses disability across six domains, including understanding and communicating, getting around, self-care, getting along with people, life activities (i.e., household, work, and/or school activities), and participation in society. Translated version of scale has been used in previous trials in Pakistan(Naeem et al., 2015) . Higher score indicates more disability, ranging from 0 to 100, where 0 = no disability; 100 = full disability.	Changes from baseline to 4th and 6th month
Secondary	Problem Solving Inventory-(PSI) (Heppner, 1988):	The PSI is one of the most widely used self-report inventories in problem solving. The PSI assesses an individual's awareness and evaluation of his or her problem-solving abilities or style, and this provides a global appraisal of that individual as a problem solver. Higher score indicates better problem solving that ranges from 32 to 192.	Changes from baseline to 4th and 6th month
Secondary	The General Self-Efficacy Scale (GSES) (Schwarzer & Jerusalem, 2010):	The GSES is a simple 10 item self-administered scale. The scale is developed to assess a general sense of perceived self-efficacy with the aim to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. A total score ranges from 10 to 40. Higher scores indicate higher perceived general self-efficacy, lower scores indicate lower perceived general self-efficacy.	Baseline, 4th and 6th month
Secondary	The Postpartum Bonding Questionnaire (PBQ) (Brockington, Fraser, & Wilson, 2006):	The PBQ is designed to detect disturbance in the mother-child relationship. The scale has25 items, each followed by six alternative responses ranging from 'always' to 'never'. Positive responses, such as ''I enjoy playing with my baby'', are scored from zero ('always') to 5 ('never'). Negative responses, such as ''I am afraid of my baby'', are scored from 5 ('always') to zero ('never'). A high score indicates pathology in mother-child relationship. Higher score indicates more strong bonding	Changes from baseline to 4th and 6th month
Secondary	Assessment of the growth and development of children: Weight	Data on child growth: Anthropometric measures of child growth will be collected through measuring children's weight in kilogram	Change in weight from Baseline and 6th month
Secondary	Assessment of the growth and development of children: Height	Data on child growth: Anthropometric measures of child growth will be collected through measuring children's height in meters at baseline, and 6 months after baseline.	change in height from Baseline and 6th month
Secondary	Assessment of the growth and development of children: Head circumference	Data on child growth: Anthropometric measures of child growth will be collected through measuring children's head circumference in centimeters at baseline, and 6 months after baseline.	change in head circumference measurement from Baseline and 6th month
Secondary	Ages and Stages Questionnaire (ASQ) and ASQ Socio-emotional Scales (ASQ: SE) (Squires et al., 2015),	parent-reported screening instrument comprising of 25/29 items on social and emotional difficulties recommended for evaluating early interventions.	Changes from baseline to 4th and 6th month
Secondary	Manchester Assessment of Caregiver-Infant Interaction (MACI) (Wan, Brooks, Green, Abel, & Elmadih, 2017):	This validated global rating measure evaluates qualities of observed parent-child interaction from 6-minute video clips of unstructured play interaction. It comprises of seven seven-point rating scales that covers key characteristics of interaction, such as caregiver sensitive responsiveness, child attentiveness to caregiver, and level of mutuality, which are understood to reflect the quality of the parent-child relationship and the child's social and emotional environment. Due to the resource requirements of an observational measure, 5% from each intervention arm will be selected randomly for MACI assessment.	Baseline and 4th month
Secondary	Bayley Scales of Infant Development (Bayley, 1993):	It is a standard series of measurements to assess the development of infants and toddlers, ages 1-42 months. This measure consists of a series of developmental play tasks and takes between 45 - 60 minutes to administer. The Bayley is an early childhood, norm-referenced assessment instrument that evaluates the current level of functioning for young children. The instrument, which is individually administered by qualified professionals, assesses developmental domains such as language, cognitive, personal/social, fine motor, and gross motor skills. The assessment of these skills in conjunction with other forms. Other specific purposes of the Bayley are to identify possible developmental delays and inform professionals about specific areas of strength or weakness when planning a comprehensive intervention and provide a method of monitoring a child's developmental progress.	Baseline and 6th month
Secondary	Home Observation for Measurement of the Environment (HOME) (Caldwell & Bradley, 1984):	HOME is a descriptive pro?le which yields a systematic assessment of the caring environment in which the child is reared. The primary goal of the scale is to measure, with in a naturalistic context, the quality and quantity of stimulation and support available to a child in home environment. It contains 45 items under 6 subscales which are; 1. Emotional and verbal responsively of the primary caregiver (item 1-11); 2. Avoidance of restriction and punishment (item 12-19); 3. Organization of the physical and temporal environment (item 20-25); 4. Provision of appropriate play materials (item 26-34); 5. Parental involvement with the child (item 35-40), 6. Opportunity for variety in daily stimulation (item 40-45).	Changes from baseline to 4th and 6th month
Secondary	World Health Organisation Quality of Life (WHOQOL-BREF) (WHO, 1997)	The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely.	Changes from baseline to 4th and 6th month