Building Resilience Against ViolencE (BRAVE)

Sponsor

Pakistan Institute of Living and Learning (Other)

Overall Status

Completed

CT.gov ID

NCT03488290

Collaborator

(none)

300

Enrollment

Locations

Arms

40.4

Actual Duration (Months)

150

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Behavioral: LTP Plus TF-CBT Other: Treatment as Usual	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This will be a two arm study: 1) LTP Plus TF-CBT added to TAU 2) Treatment as usual (TAU)This will be a two arm study: 1) LTP Plus TF-CBT added to TAU 2) Treatment as usual (TAU)

Masking:

Single (Outcomes Assessor)

Masking Description:

Researchers doing outcome assessment will be kept blind to the group allocations

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 20, 2018

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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	Behavioral: LTP Plus TF-CBT 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 Other: Treatment as Usual The Treatment as Usual group will receive routine care
Other: Treatment as Usual TAU group will receive routine care consisting of routine follow ups	Other: Treatment as Usual The Treatment as Usual group will receive routine care

Arm

Intervention/Treatment

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

Behavioral: LTP Plus TF-CBT

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

Other: Treatment as Usual

The Treatment as Usual group will receive routine care

Other: Treatment as Usual

TAU group will receive routine care consisting of routine follow ups

Other: Treatment as Usual

The Treatment as Usual group will receive routine care

Outcome Measures

Primary Outcome Measures

Clinically administered PTSD Scale-5 (CAPS-5) [Changes from Baseline to 4th Month]
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.

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9) [Changes from Baseline to 4th Month]
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.
Generalized Anxiety Disorder (GAD) 7 [Changes from Baseline to 4th Month]
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.
Client Service Receipt Inventory (CSRI) [Changes from Baseline to 4th Month]
This will be used to collect information about the use of other health services (including the informal sector faith healers/Imams).
Ages and Stages Questionnaire [Changes from Baseline to 4th Month]
To assess physical, social, emotional and cognitive development of children.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.