Post Traumatic Stress DisorderBRAVENCT03488290
Building Resilience Against ViolencE (BRAVE)
A study testing LTP Plus TF-CBT and Treatment as Usual in people with Post Traumatic Stress Disorder, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- LTP Plus TF-CBT and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesPakistan
- Study dates
- 20 Apr 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Pakistan2 sites
Schools, Community
Karachi, Sindh
Schools, Community
Peshawar, Khyber Pakhtunkhwa
About this study
Official title: Building Resilience Against ViolencE (BRAVE): A Parenting Intervention for Mothers and Fathers With Post-traumatic Stress Symptoms.
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)
Read the 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
- Being tested
- LTP Plus TF-CBT, Treatment as Usual
- Keywords
- Parents, Young Children, Trauma Focused Cognitive Behavior Therapy, Learning Through Play
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTP Plus TF-CBTBehavioural
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
Treatment as UsualOther
The Treatment as Usual group will receive routine care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: LTP Plus TF-CBT; Other: Treatment as Usual |
| Treatment as Usual | Other | TAU group will receive routine care consisting of routine follow ups Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from Baseline to 4th Month
Secondary outcomes (4)
Patient Health Questionnaire (PHQ-9)
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.
Measured: Changes from Baseline to 4th Month
Generalized Anxiety Disorder (GAD) 7
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.
Measured: Changes from Baseline to 4th Month
Client Service Receipt Inventory (CSRI)
This will be used to collect information about the use of other health services (including the informal sector faith healers/Imams).
Measured: Changes from Baseline to 4th Month
Ages and Stages Questionnaire
To assess physical, social, emotional and cognitive development of children.
Measured: Changes from Baseline to 4th Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start20 Apr 2018
- Primary completion1 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a two arm study: 1) LTP Plus TF-CBT added to TAU 2) Treatment as usual (TAU)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Chaudhry, Principal investigator, Pakistan Institute of Living & Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488290
- Sponsor's protocol ID
- PILL-BRAVE01
- Acronym
- BRAVE
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17721954Byrne 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.
PubMed 9125790Cartwright 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.
PubMed 28596856Dubrow 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.
PubMed 2914517El-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.
PubMed 28596884El-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.
PubMed 23993182
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resilience Against ViolencE (BRAVE): A Parenting Intervention for Mothers and Fathers With Post-traumatic Stress Symptoms.
- ClinicalTrials.gov ID
- NCT03488290
- Acronym / sponsor ID
- BRAVE / PILL-BRAVE01
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Parents, Young Children, Trauma Focused Cognitive Behavior Therapy, Learning Through Play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a two arm study: 1) LTP Plus TF-CBT added to TAU 2) Treatment as usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| LTP Plus TF CBT | Experimental | Behavioral: LTP Plus TF-CBT, Other: Treatment as UsualLTP 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 as Usual | Other | Other: Treatment as UsualTAU group will receive routine care consisting of routine follow ups |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTP Plus TF-CBTExperimental: 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 | Behavioural | LTP Plus TF CBT |
| Treatment as UsualThe Treatment as Usual group will receive routine care | Other | LTP Plus TF CBT, Treatment as Usual |
Primary outcome
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.
4 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Changes from Baseline to 4th Month
Generalized Anxiety Disorder (GAD) 7
Time frame: Changes from Baseline to 4th Month
Client Service Receipt Inventory (CSRI)
Time frame: Changes from Baseline to 4th Month
Ages and Stages Questionnaire
Time frame: Changes from Baseline to 4th Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Background: PubMed 17721954Allen 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.
- Background: PubMed 9125790Byrne 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.
- Background: PubMed 28596856Cartwright 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.
- Background: PubMed 2914517Dubrow 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.
- Background: PubMed 28596884El-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.
- Background: PubMed 23993182El-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.
Related trials for Post Traumatic Stress Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasim Chaudhry principal investigator
Pakistan Institute of Living & Learning
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTP Plus TF-CBT and Treatment as Usual in people with Post Traumatic Stress Disorder, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically administered PTSD Scale-5 (CAPS-5) (time frame: Changes from Baseline to 4th Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488290, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.