Posttraumatic Stress Disorder Clinical Trial
— RELATEOfficial title:
Addressing Elevated PTSD Symptoms in Young People in Care: A Randomised Feasibility Trial Across Social-care and Mental Health Services.
NCT number | NCT04467320 |
Other study ID # | 274914 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2020 |
Est. completion date | December 1, 2021 |
Verified date | March 2021 |
Source | University of Bath |
Contact | Rebecca Davis |
Phone | 07929827482 |
rsd52[@]bath.ac.uk | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Most children who have been removed from their family home and placed under the care of a Local Authority have been exposed to many frightening experiences, including witnessing violence, not being fed or cared for, or being abused. These experiences can lead to significant emotional difficulties. One such difficulty is posttraumatic stress disorder (PTSD), which can involve symptoms like having constant "flashbacks" of scary experiences, and a constant feeling of being in danger. This can have a big effect on children's lives. Yet, it is still not clear how to help young people in care who are experiencing high PTSD symptoms. One idea the researchers have is to use a group-based online programme which has successfully helped other young people who have been exposed to different kinds of stressful experiences (for example, war). To test whether this programme could help children in care too, the researchers first need to see whether social workers have the time to check in with a child about PTSD symptoms; whether young people and their carers are willing to be involved in a research project which will test out the treatment programme; and whether mental health workers might face any problems when delivering the programme. This project aims to answer these questions. The researchers will train social workers to complete an 8-question interview with 10-17 year olds in care, which will measure symptoms of PTSD. If the young person is experiencing high symptoms, they will be invited to take part in a research project. If they would like to join the project, children will be randomly selected to take part in the online group programme, or be given care-as-usual. The group programme involves the young person taking part in five weekly meetings held online, where they will learn skills to reduce their distress, and be supported to work through their difficult memories. Their carers will also take part in two online meetings which will teach them how to support their young person.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | Inclusion Criteria: - Experiencing elevated PTSS (using a standard cut-off score of =/> 17 on the 8-item Child Revised Impact of Events Scale; CRIES-8). - Living in any care residence (with the exception of those living with a biological parent). - Access to appropriate technology to engage in the online sessions and can do so in a quiet and private space. Exclusion Criteria: - A diagnosis of psychosis. - Current and active serious suicidal ideations. - A moderate to severe learning disability. - Currently receiving direct therapeutic mental health support. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Bath | Bath |
Lead Sponsor | Collaborator |
---|---|
University of Bath | Avon and Wiltshire Mental Health Partnership NHS Trust, King's College London, National Institute for Health Research, United Kingdom, University of Bristol, University of East Anglia, University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Focus groups and 1:1 semi-structured interviews | Qualitative measures carried out with young people, carers and service providers | 2 months | |
Primary | Child and Adolescent Trauma Screen (CATS) | Self-report DSM-5 post-traumatic stress disorder (PTSD) symptom measure. Scores range from 0-60, with greater scores indicating greater symptom severity. | 6 months | |
Secondary | Child Revised Impact of Events Scale (CRIES-8) | Self-report post-traumatic stress disorder (PTSD) symptom screening tool. Symptom scores range from 0-40, with higher scores indicating greater symptom severity. | 6 months | |
Secondary | Child PTSD Symptom Scale (CPSS-5) Interview Schedule | DSM-5 PTSD diagnostic interview. Symptoms range from 0-80, with higher scores indicating greater symptom severity. | 6 months | |
Secondary | Inventory of Parent and Peer Attachment (IPPA) | Self-report measure of young person's perception of their relationship with their carer. Scores range from 28-140, with lower scores indicating greater relationship difficulties. | 6 months | |
Secondary | Strengths and Difficulties Questionnaire (SDQ) | Self-report and carer-report measure of internalising and externalising difficulties. There are 5 subscales each with scores ranging from 0-10. The total difficulties score is calculated by summing 4 of the sub-scales to give a score between 0-40. The greater the total score, the greater the difficulties experienced. | 6 months | |
Secondary | Short Mood and Feelings Questionnaire (SMFQ) | Self-report and carer-report depression questionnaire. Scores range from 0-26, with higher scores indicating more depressive symptoms. | 6 months | |
Secondary | Child Health Utility 9D (CHU9D) | Self-report measure of health-related quality of life. Scores range from 9-45, with higher scores indicating greater difficulties. | 6 months | |
Secondary | Parent Trauma Response Questionnaire - support style subscale (PTRQ) | Carer-report measure of their support style. Scores range from 0-30, with higher scores indicating greater difficulties. | 6 months | |
Secondary | Child and Adolescent Trauma Screen (carer report) | Carer-report young person PTSD symptom scale. Symptom scores range from 0-60, with higher scores indicating greater symptom severity. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03384706 -
A Comparison of CPT Versus ART Versus WL
|
N/A | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03129204 -
Sensation Awareness Focused Training for Spouses
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Completed |
NCT05113277 -
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
|
N/A | |
Recruiting |
NCT05327504 -
Written Exposure Therapy for Veterans With SUD and PTSD
|
N/A | |
Recruiting |
NCT05843695 -
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Completed |
NCT00644423 -
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT02989987 -
NET for SGBV Survivors in Eastern DR Congo
|
N/A | |
Completed |
NCT02320799 -
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
|
N/A | |
Recruiting |
NCT02293291 -
Thermal Clinic Treatment in Gulf War Illness
|
Phase 1/Phase 2 | |
Completed |
NCT02242136 -
Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants
|
N/A | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A | |
Completed |
NCT02720497 -
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
|
N/A | |
Completed |
NCT01693978 -
Contingency Outcomes in Prolonged Exposure
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01469754 -
Longitudinal Survey Analysis in Lymphoma Survivors
|
N/A | |
Terminated |
NCT01239173 -
Emotional Memory Reactivation in Posttraumatic Stress Disorder
|
Phase 3 | |
Completed |
NCT02362477 -
Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
|
Phase 3 |