Building Resilience Against ViolencE (BRAVE)

Post Traumatic Stress Disorder Clinical Trial

— BRAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488290
• Other study ID #: PILL-BRAVE01
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: April 2022
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Pakistan	Schools, Community	Karachi	Sindh
Pakistan	Schools, Community	Peshawar	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Allen B, Lauterbach D. Personality characteristics of adult survivors of childhood trauma. J Trauma Stress. 2007 Aug;20(4):587-95. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Ages and Stages Questionnaire	To assess physical, social, emotional and cognitive development of children.	Changes from Baseline to 4th Month