NCT03488290

Building Resilience Against ViolencE (BRAVE)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-04-20
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2018-04-04
• Last updated: 2022-04-25

Locations

2 sites across 1 country: Pakistan