Building Resilience Against ViolencE (BRAVE)

Pakistan Institute of Living and Learning

Status: Completed

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: LTP Plus TF-CBT; Other: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03488290

PILL-BRAVE01

Details and patient eligibility

About

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)

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 2 patient groups

LTP Plus TF CBT

Experimental group

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

Treatment:

Behavioral: LTP Plus TF-CBT

Other: Treatment as Usual

Treatment as Usual

Other group

Description:

TAU group will receive routine care consisting of routine follow ups

Treatment:

Other: Treatment as Usual