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Building Resilience Against ViolencE (BRAVE) (BRAVE)

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
LTP Plus TF-CBT
Treatment as Usual
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Parents, Young Children, Trauma Focused Cognitive Behavior Therapy, Learning Through Play

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Schools, Community
  • Schools, Community

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

LTP Plus TF CBT

Treatment as Usual

Arm Description

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

TAU group will receive routine care consisting of routine follow ups

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
Ages and Stages Questionnaire
To assess physical, social, emotional and cognitive development of children.

Full Information

First Posted
March 28, 2018
Last Updated
April 22, 2022
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT03488290
Brief Title
Building Resilience Against ViolencE (BRAVE)
Acronym
BRAVE
Official Title
Building Resilience Against ViolencE (BRAVE): A Parenting Intervention for Mothers and Fathers With Post-traumatic Stress Symptoms.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Parents, Young Children, Trauma Focused Cognitive Behavior Therapy, Learning Through Play

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a two arm study: 1) LTP Plus TF-CBT added to TAU 2) Treatment as usual (TAU)
Masking
Outcomes Assessor
Masking Description
Researchers doing outcome assessment will be kept blind to the group allocations
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LTP Plus TF CBT
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
TAU group will receive routine care consisting of routine follow ups
Intervention Type
Behavioral
Intervention Name(s)
LTP Plus TF-CBT
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
The Treatment as Usual group will receive routine care
Primary Outcome Measure Information:
Title
Clinically administered PTSD Scale-5 (CAPS-5)
Description
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.
Time Frame
Changes from Baseline to 4th Month
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Changes from Baseline to 4th Month
Title
Generalized Anxiety Disorder (GAD) 7
Description
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.
Time Frame
Changes from Baseline to 4th Month
Title
Client Service Receipt Inventory (CSRI)
Description
This will be used to collect information about the use of other health services (including the informal sector faith healers/Imams).
Time Frame
Changes from Baseline to 4th Month
Title
Ages and Stages Questionnaire
Description
To assess physical, social, emotional and cognitive development of children.
Time Frame
Changes from Baseline to 4th Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasim Chaudhry
Organizational Affiliation
Pakistan Institute of Living & Learning
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schools, Community
City
Peshawar
State/Province
Khyber Pakhtunkhwa
Country
Pakistan
Facility Name
Schools, Community
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17721954
Citation
Allen B, Lauterbach D. Personality characteristics of adult survivors of childhood trauma. J Trauma Stress. 2007 Aug;20(4):587-95. doi: 10.1002/jts.20195.
Results Reference
background
PubMed Identifier
9125790
Citation
Byrne CA, Riggs DS. The cycle of trauma; relationship aggression in male Vietnam veterans with symptoms of posttraumatic stress disorder. Violence Vict. 1996 Fall;11(3):213-25.
Results Reference
background
PubMed Identifier
28596856
Citation
Cartwright K, El-Khani A, Subryan A, Calam R. Establishing the feasibility of assessing the mental health of children displaced by the Syrian conflict. Glob Ment Health (Camb). 2015 Jun 19;2:e8. doi: 10.1017/gmh.2015.3. eCollection 2015.
Results Reference
background
PubMed Identifier
2914517
Citation
Dubrow NF, Garbarino J. Living in the war zone: mothers and young children in a public housing development. Child Welfare. 1989 Jan-Feb;68(1):3-20.
Results Reference
background
PubMed Identifier
28596884
Citation
El-Khani A, Cartwright K, Redmond A, Calam R. Daily bread: a novel vehicle for dissemination and evaluation of psychological first aid for families exposed to armed conflict in Syria. Glob Ment Health (Camb). 2016 Apr 22;3:e15. doi: 10.1017/gmh.2016.9. eCollection 2016.
Results Reference
background
PubMed Identifier
23993182
Citation
El-Khani A, Ulph F, Redmond AD, Calam R. Ethical issues in research into conflict and displacement. Lancet. 2013 Aug 31;382(9894):764-5. doi: 10.1016/S0140-6736(13)61824-3. No abstract available.
Results Reference
background

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Building Resilience Against ViolencE (BRAVE)

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