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Building Resilience Against ViolencE (BRAVE) (BRAVE)

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ClinicalTrials.gov Identifier: NCT03488290
Recruitment Status : Not yet recruiting
First Posted : April 4, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

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, clinicians, GPs and people delivering the LTP plus TF CBT intervention.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: LTP Plus TF-CBT Other: Treatment as Usual Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a two arm study: 1) LTP Plus TF-CBT added to TAU 2) Treatment as usual (TAU)
Masking: Single (Outcomes Assessor)
Masking Description: Researchers doing outcome assessment will be kept blind to the group allocations
Primary Purpose: Treatment
Official Title: Building Resilience Against ViolencE (BRAVE): A Parenting Intervention for Mothers and Fathers With Post-traumatic Stress Symptoms.
Estimated Study Start Date : April 20, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Arm Intervention/treatment
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
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

Treatment as Usual
TAU group will receive routine care consisting of routine follow ups
Other: Treatment as Usual
The Treatment as Usual group will receive routine care




Primary Outcome Measures :
  1. Clinically administered PTSD Scale-5 (CAPS-5) [ Time Frame: Changes from Baseline to 4th Month ]
    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 :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: Changes from Baseline to 4th Month ]
    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.

  2. Generalized Anxiety Disorder (GAD) 7 [ Time Frame: Changes from Baseline to 4th Month ]
    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.

  3. Client Service Receipt Inventory (CSRI) [ Time Frame: Changes from Baseline to 4th Month ]
    This will be used to collect information about the use of other health services (including the informal sector faith healers/Imams).

  4. Ages and Stages Questionnaire [ Time Frame: Changes from Baseline to 4th Month ]
    To assess physical, social, emotional and cognitive development of children.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488290


Contacts
Contact: Sana Farooque 021-35871845 sana.farooque@pill.org.pk
Contact: Shafaq Ejaz shafaq.ejaz@pill.org.pk

Locations
Pakistan
Schools, Community Not yet recruiting
Peshawar, Khyber Pakhtunkhwa, Pakistan
Schools, Community Not yet recruiting
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Pakistan Institute of Living and Learning
Investigators
Principal Investigator: Nasim Chaudhry Pakistan Institute of Living & Learning

Publications:
Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT03488290     History of Changes
Other Study ID Numbers: PILL-BRAVE01
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pakistan Institute of Living and Learning:
Parents
Young Children
Trauma Focused Cognitive Behavior Therapy
Learning Through Play

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders