Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Feasibility measure |
The feasibility will be determined by collating data on recruitment and retention rates. The success criterion of feasibility will be to recruit > 50% of eligible participants. |
From baseline to 12th week (at the end of intervention) |
|
Primary |
Acceptability measure |
The intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of >70% of at least 7 sessions. |
From baseline to 12th week (at the end of intervention) |
|
Secondary |
Suicide Attempt Self-Injury Interview |
Repetition rate of self-harm at 3 months after randomisation as measured by adapted Suicide Attempt Self-Injury Interview. The questionnaire records self-harm events by severity and chronological order. |
From baseline to 12th week |
|
Secondary |
Beck Scale for Suicide Ideation |
This is a 19-item instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviours, and specificity of a patient's thoughts to kill him/herself during the past week. |
Change in problem scores from baseline to 12th week |
|
Secondary |
Beck Depression Inventory |
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression. |
Change in problem scores from baseline to 12th week |
|
Secondary |
Beck Hopelessness Scale |
This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations. |
Change in problem scores from baseline to 12th week |
|
Secondary |
Generalized Anxiety Disorder |
This is a 7-item scale used to screen for and measure severity of Generalized Anxiety Disorder. |
Change in problem scores from baseline to 12th week |
|
Secondary |
Assessment of the growth and development of children |
Anthropometric measures of child growth will be collected through measuring children's height, weight and head circumference |
Change from baseline to 12th week |
|
Secondary |
Ages and Stages Questionnaire and ASQ Socio-emotional Scales |
Ages and Stages Questionnaire and ASQ Socio-emotional scales 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 at different time points. |
Change from baseline to 12th week |
|
Secondary |
Coping resource inventory |
Coping resource inventory will assess the coping resources to manage stress available to an individual. |
Change from baseline to 12th week |
|
Secondary |
Problem Solving Inventory |
The Problem-Solving Inventory assesses an individual's awareness and evaluation of his or her problem-solving abilities or styles. The problem-solving Inventory is a self-report measure, and thus assesses perceptions of problem solving as opposed to actual problem-solving skills. |
Change in problem scores from baseline to 12th week |
|
Secondary |
Infant Development Questionnaire |
Infant Development Questionnaire is a 20-item questionnaire of paternal knowledge and expectations for child development in the first three years. |
Change from baseline to 12th week |
|
Secondary |
Parenting Stress Index - Short Form |
Parents rated 36 item scale on five-point scale (1-5). The scale consists of three subscales: (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction. |
Change from baseline to 12th week |
|
Secondary |
Multidimensional Scale of Perceived Social Support |
This brief scale will assess perceived social support. |
Change from baseline to 12th week |
|
Secondary |
Euro-Qol-5 Dimensions scale |
Health-related quality of life will be measured using the Euro-Qol-5 Dimensions scale. 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". |
Change in problem scores from baseline to 12th week |
|
Secondary |
Client Service Receipt Inventory |
This inventory will collect information about the use of other health services (including the informal sector faith healers/Imams) using CSRI based on our previous work in Pakistan |
Change from baseline to 12th week |
|
Secondary |
Client Satisfaction Questionnaire |
The participants will rate their satisfaction with treatment using the Client Satisfaction Questionnaire. |
Change from baseline to 12th week |
|