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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2022 |
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Main ID: |
NCT03488290 |
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Date of registration:
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28/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Building Resilience Against ViolencE (BRAVE)
BRAVE |
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Scientific title:
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Building Resilience Against ViolencE (BRAVE): A Parenting Intervention for Mothers and Fathers With Post-traumatic Stress Symptoms. |
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Date of first enrolment:
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April 20, 2018 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03488290 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Nasim Chaudhry |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pakistan Institute of Living & Learning |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Post Traumatic Stress Disorder
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Intervention(s)
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Behavioral: LTP Plus TF-CBT
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Other: Treatment as Usual
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Primary Outcome(s)
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Clinically administered PTSD Scale-5 (CAPS-5)
[Time Frame: Changes from Baseline to 4th Month]
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Secondary Outcome(s)
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Generalized Anxiety Disorder (GAD) 7
[Time Frame: Changes from Baseline to 4th Month]
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Patient Health Questionnaire (PHQ-9)
[Time Frame: Changes from Baseline to 4th Month]
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Ages and Stages Questionnaire
[Time Frame: Changes from Baseline to 4th Month]
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Client Service Receipt Inventory (CSRI)
[Time Frame: Changes from Baseline to 4th Month]
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Secondary ID(s)
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PILL-BRAVE01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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