Building Resilience Against ViolencE (BRAVE)

Study Overview
=================
Brief Summary
-----------------
The study has both quantitative and qualitative components. The objective of the quantitative study is: To evaluate the effectiveness of Learning Through Play (LTP) Plus culturally adapted Trauma Focused Cognitive Behavior Therapy (TF-CBT) for post-traumatic stress symptoms in parents. The objective of the qualitative study is: To find out facilitators and barriers from the perspective of the participants and other stakeholders (e.g., clinicians, GPs, people delivering the LTP plus TF CBT intervention etc)

Detailed Description
-----------------
Despite the high prevalence of post-traumatic stress disorder in Pakistan, research on psychosocial intervention is limited. We propose to investigate the acceptability, feasibility and effectiveness of manual assisted Learning Through Play (LTP) Plus culturally adapted Trauma Focused Cognitive Behavior Therapy (TF-CBT) among parents experiencing Post Traumatic Stress Disorder (PTSD). LTP Plus is proposed as a low cost intervention to improve parents' mental and physical health, and promote healthy child development. 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. This will be integrated with Trauma Focused CBT. Purpose of this RCT is to determine the effectiveness of LTP plus TF- CBT intervention. The study will be conducted in two cities of Pakistan, Karachi and Peshawar.Participants will be screened using Impact of Event Scale-Revised (IES-R) and eligibility checklist. Those scoring 24 or above will be eligible for more in depth assessment. Assessments will be done at baseline and after completion of intervention. Outcome assessments will be done by independent Research Assistants blind to group allocations.

Official Title
-----------------
Building Resilience Against ViolencE (BRAVE): A Parenting Intervention for Mothers and Fathers With Post-traumatic Stress Symptoms.

Conditions
-----------------
Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: LTP Plus TF-CBT
* Other: Treatment as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be included in the study if they are: Parents over the age of 16 years who are living with their children age 3-6 years. They meet the criteria for Post-Traumatic Stress Disorder (PTSD) and are able to give informed consent Exclusion Criteria: Participants will be excluded from the study if they have: Any diagnosed physical or learning disability which prevents them from attending the LTP+ group intervention, or suffering from psychosis or those who are actively suicidal. This will be assessed by the research team at screening stage. Any disabilities or diagnosed mental illness. Any parent who is on current use of anti-depressant medication. And a prior self-reported mental illness, including depression.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a two arm study: 1) LTP Plus TF-CBT added to TAU 2) Treatment as usual (TAU)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTP Plus TF CBT<br>LTP Plus TF CBT group participants will receive group intervention by masters' level trained facilitators weekly during the first two months and then fortnightly. It comprises of two components i.e. LTP and TF CBT. LTP aims at enabling parents to improve their child's psychosocial development by educating about child development and the importance of mother-child play. TF CBT aim is to modify excessively negative appraisals of the trauma and its sequelae by careful questioning | Behavioral: LTP Plus TF-CBT<br>* Experimental: LTP Plus TF-CBT LTP Plus TF-CBT group participants will receive group intervention by masters' level trained facilitators weekly during the first two months and then fortnightly. It comprises of two components i.e. LTP and TF CBT. LTP aims at enabling parents to improve their child's psychosocial development by educating about child development and the importance of mother-child play. TF CBT aim is to modify excessively negative appraisals of the trauma and its sequelae by careful questioning<br>Other: Treatment as Usual<br>* The Treatment as Usual group will receive routine care<br>|
| Other: Treatment as Usual<br>TAU group will receive routine care consisting of routine follow ups | Other: Treatment as Usual<br>* The Treatment as Usual group will receive routine care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically administered PTSD Scale-5 (CAPS-5) | The Clinical Administered PTSD Scale-5 (CAPS-5) is a 30 item scale and will be used as a primary outcome measure as this is the goal standard and structured interview for assessing post-traumatic stress disorder (PTSD), diagnostic status and symptom severity (Weathers et al., 2013).Higher score indicate greater severity. | Changes from Baseline to 4th Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | PHQ-9 is 10 items self-report questionnaire which is easy to use and can be administered by a trained research worker. A score of 10 or above is taken as cut -off point for depressive disorder. This scale will be used to check severity of depression.Higher score indicate greater severity of depression. | Changes from Baseline to 4th Month | 
| Generalized Anxiety Disorder (GAD) 7 | The GAD-7 is a seven item scale will be used to screen for and measure severity of Generalized Anxiety Disorder. Higher score indicate greater severity of anxiety. | Changes from Baseline to 4th Month | 
| Client Service Receipt Inventory (CSRI) | This will be used to collect information about the use of other health services (including the informal sector faith healers/Imams). | Changes from Baseline to 4th Month | 
| Ages and Stages Questionnaire | To assess physical, social, emotional and cognitive development of children. | Changes from Baseline to 4th Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parents, Young Children, Trauma Focused Cognitive Behavior Therapy, Learning Through Play