The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers.
Most research on the association between parental depression and child outcomes has focused mainly on mothers. However, studies suggest that the relationship between parental depression and child outcome is not necessarily limited to mothers. The study has two phases quantitative and qualitative: Purpose of this quantitative phase is to determine if the LTP plus programme delivered by non-specialists and community health workers reduces symptoms of paternal depression and improves child development compared to treatment as usual. In the qualitative part of the study focus groups and in-depth digitally recorded interviews will be conducted with participants by trained research staff at two-time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. In addition, Participants who refused to participate in the trial will be asked if they would be willing to be contacted by a researcher to discuss their reasons for not taking part. Moreover, in-depth digitally-recorded interviews with stakeholders (grandparents, therapists, health professionals, etc) will also be conducted by trained researchers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
357
LTP+Dads is a 12 - session group integrated parenting intervention: i.e LTP (Learning through Play) 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. In each stage, there are five areas of child development: sense of self, physical, relationships, understanding, and communication. All areas are written in simple, low-literacy language. Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood. 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.
Bin Qasim Town
Karachi, Sindh, Pakistan
Orangi Town
Karachi, Sindh, Pakistan
Hamilton Depression Scale HAM-D 17 (Hamilton, 1960)
The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The HAM-D is a simple 17 item self-report questionnaire can also be administered by a trained research worker. The translated version of the scale has been used in previous studies in Pakistan (Husain et al., 2017). It takes about 10 to 15 minutes to administer this scale. A score of 0-7 indicates normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression and \> 22 severe depression
Time frame: Changes from Baseline to 4th and 6th Month
Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):
The GAD-7 is a 7-item scale used to screen for and measure severity of generalized anxiety disorder. Scores of 5, 10 \& 15 are taken as cut-off points for mild, moderate and high. it takes about 5 minutes to administer this scale.
Time frame: Changes from Baseline to 4th and 6th Month
Rosenberg's Self-Esteem Scale (Rosenberg, 1995)
Rosenberg's Self-Esteem Scale will be used to measure self-esteem and personal worthlessness. It is a simple 9 item questionnaire. Higher scores indicate higher self-esteem. The Urdu translated version of scale has been used in our previous studies in Pakistan. (Husain et al 2014; Husain et al., 2017).The scale takes about 5 to 10 minutes to administer
Time frame: Changes from Baseline to 4th and 6th Month
Brief Disability Questionnaire BDQ:(Von Korff, Ustun, Ormel, Kaplan, & Simon, 1996)
BDQ is a simple 8 Items questionnaire to measure disability in the physical or social life. Total scores across items 1-6 are considered to indicate 'moderate' and 'severe' disability for score ranges 8-13 and 14-22 respectively. The translated version of scale has been used in previous trials in Pakistan (Naeem et al., 2015). It takes about 5 to 10 minutes to administer this scale
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Time frame: Changes from Baseline to 4th and 6th Month
Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003)
The Patient health Questionnaire (PHQ-9) is 10 items self-report questionnaire which is easy to use and can be administered by a trained research worker. Score ranges from : 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Time frame: Changes from Baseline to 4th and 6th Month
Client Satisfaction Questionnaire (CSQ) (Attkisson & Greenfield, 1995)
The participants will rate their satisfaction with the intervention at 4th month using the CSQ, it comprises of 8 items, high scores indicate greater satisfaction (Attkisson \& Greenfield, 1995). it takes about 5 minutes to administer this scale
Time frame: After completion of the intervention at 4th month only
Parenting Scale (Arnold, O'leary, Wolff, & Acker, 1993)
Parent-completed 30-item questionnaire measuring three dysfunctional discipline styles: (1) laxness (permissive discipline), (2) over-reactivity (authoritarian discipline) and (3) verbosity (reliance on talking), with responses rated on a seven-point scale. it takes about 10 minutes to administer this scale.
Time frame: Changes from Baseline to 4th and 6th Month
Euro-Qol-5 Dimensions (EQ-5D) ( Brooks R. EuroQol,.1996)
Health-related quality of life will be measured by using EQ-5D. This is a standardized instrument that measures five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each scored from 1 to 3 indicating "no problem" to "severe problems". In both the visual analogue scale, and the standardized valuation score, lower scores indicate poorer QOL. It takes about 5 minutes to administer this scale.
Time frame: Changes from Baseline to 4th and 6th Month
Hurt, Insulted, Threatened with Harm and Screamed (HITS) (Sherin, Sinacore, Li, Zitter, & Shakil, 1998):
HITS is simple 4 item domestic violence screening tool. Each item is scored from 1-5. Range between 4-20. A score greater than 10 signify that an individual are at risk of domestic violence. It takes about 5 minutes to administer this scale. An adapted version of the scale is being used in this study.
Time frame: Changes from Baseline to 4th and 6th Month
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). A total DAS score, ranging from 0 to 150, is derived by summing across the four subscales. The 32 items of the DAS are answered on Likert-type scales with questions representing each of the four subscales distributed throughout.It takes about 10 to 15 minutes to administer. The culturally adapted version of the scale is being used in this study.
Time frame: Changes from Baseline to 4th and 6th Month
Knowledge of Expectation and Child Development
A 25-item questionnaire will be used to assess paternal knowledge and expectations for child development in the first three years. Higher score indicated higher knowledge about child development. (Husain et al 2017) .It takes about 5 to 10 minutes to administer this scale
Time frame: Changes from Baseline to 4th and 6th Month
OSLO 3 (Nosikov & Gudex, 2003)
Oslo-3 Items social support scale focuses on the quality of social network, perceived positive interest and concern from other people and available help from neighbors if necessary. A score of 3-8 is "poor support", 9-11 is "moderate support" and 12-14 is "strong support". The Urdu version of the scale has already been used in previous studies in Pakistan(Husain, Chaudhry, Jafri, et al., 2014). it takes about 5 minutes to administer this scale.
Time frame: Changes from Baseline to 4th and 6th Month
Parenting Stress Index - Short Form (Abidin, 1995)
Parents rate 36 items on a five-point rating scale (1-5) on three sub scales: (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction. it takes about 10 to 15 minutes to administer this scale.
Time frame: Changes from Baseline to 4th and 6th Month
Eyberg Child Behaviour Inventory (ECBI) (Eyberg, Boggs, & Reynolds, 1980)
The ECBI is a parent rating scale consisting of items relating specifically to behaviors associated with conduct problems in children. The ECBI is a behaviorally specific instrument consisting of a list of 36 behaviors. It has two scales: (a) The Intensity Scale, which indicates how often these behaviors occur, and (b) The Problem Scale, identifying which specific behaviors are considered as problems by the parents. Rating on intensity scale will be done on seven-point (1-7) whereas on problem scale with YES or NO. it takes about 10-15 minutes to administer this scale.
Time frame: Changes from Baseline to 4th and 6th Month
Manchester Assessment of Caregiver-Infant Interaction (MACI)
It is designed as a global rating measure, covering general features of parents, infant and dyadic qualities of interaction. It comprises of seven rating scales that covers broad aspects of interaction between a primary caregiver and their infant, each with a seven point scale (Wan, Brooks, Green, Abel, \& Elmadih, 2016). It is a method of systematically evaluating qualitative or global aspects of behavioural interaction between a primary caregiver and infant through rating their unstructured play from videotape. Ratings are made along a 7-point scale that show variance across the population Based on 6 minutes of caregiver-infant interaction videotaped in the lab or home.
Time frame: Changes from Baseline to 6th Month
Anthropometric measures (Weight)
Weight will be measured in Kilograms
Time frame: Changes from Baseline, to 4th and 6th Month
Anthropometric measures (Height)
Height will be measured in centimeters
Time frame: Changes from Baseline, to 4th and 6th Month
Anthropometric measures (Head Circumference)
The measurement swill be taken with a device that cannot be stretched, such as a flexible metal tape measure.
Time frame: Changes from Baseline, to 4th and 6th Month
Anthropometric measures (Arm Circumference)
The measurement swill be taken with a device that cannot be stretched, such as a flexible metal tape measure.
Time frame: Changes from Baseline, to 4th and 6th Month
Ages and Stages Social-Emotional Questionnaire(Squires et al., 2009)
This scale will be used to measure child development. Parents will report on their child's communication,gross motor, fine motor, problem solving and personal-social development. it takes about 10 minutes to administer this scale.
Time frame: Changes from Baseline to 4th and 6th Month
Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)
This scale will be used to measure child development. Parents will report on their child's communication, gross motor, fine motor, problem solving and personal-social at different time points. it takes about 15 to 20 minutes to administer this scale
Time frame: Changes from Baseline to 4th and 6th Month
Bayley Scales of Infant Development (BSID-V3) (Bayley, Nancy (2006
The Bayley Scales of Infant and Toddler Development is a standard series of measurements originally developed by psychologist Nancy Bayley used primarily to assess the development of infants and toddlers, ages 1-42 months. Scoring: 0 or 1 depending on if the child is able to perform the activity for cognitive, motor(fine and gross subscales), and language(expressive and receptive subscales) scored by examiner. Social-emotional and adaptive questionnaires filled out by parent/caregiver with same scale 0 or 1. The highest possible score on a subtest is 19, and the lowest possible score is 1. Scores from 8 to 12 are considered average.
Time frame: Changes from Baseline to 6th Month