Building Resilience Against ViolencE (BRAVE)

NCT03488290 | Completed DMC

• 1 other identifier: PILL-BRAVE01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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)

Conditions

Post Traumatic Stress Disorder

Keywords

Parents; Young Children; Trauma Focused Cognitive Behavior Therapy; Learning Through Play

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient Health Questionnaire (PHQ-9)

  Changes from Baseline to 4th Month

• Generalized Anxiety Disorder (GAD) 7

  Changes from Baseline to 4th Month

• Client Service Receipt Inventory (CSRI)

  Changes from Baseline to 4th Month

• Ages and Stages Questionnaire

  Changes from Baseline to 4th Month

Study Arms (2)

LTP Plus TF CBT

EXPERIMENTAL

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; Other: Treatment as Usual

Treatment as Usual

OTHER

TAU group will receive routine care consisting of routine follow ups

Other: Treatment as Usual

Interventions

LTP Plus TF-CBT BEHAVIORAL

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

LTP Plus TF CBT

Treatment as Usual OTHER

The Treatment as Usual group will receive routine care

LTP Plus TF CBT; Treatment as Usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (2)

Schools, Community

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

Schools, Community

Karachi, Sindh, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 17721954 BACKGROUND

• 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.

  PMID: 9125790 BACKGROUND

• 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.

  PMID: 28596856 BACKGROUND

• 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.

  PMID: 2914517 BACKGROUND

• 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.

  PMID: 28596884 BACKGROUND

• 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.

  PMID: 23993182 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Long-Term Potentiation; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nasim Chaudhry

  Pakistan Institute of Living & Learning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers doing outcome assessment will be kept blind to the group allocations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 4, 2018
• Study Start: April 20, 2018
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

PA (2)