Posttraumatic Stress DisorderRELATENCT04467320
Recovery Learning for Adolescents After Traumatic Experiences
A study testing Teaching Recovery Techniques and Care as usual in people with Posttraumatic Stress Disorder, run by University of Bath at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Teaching Recovery Techniques and Care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2020to 1 Dec 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- A diagnosis of psychosis.
- Current and active serious suicidal ideations.
- A moderate to severe learning disability.
- Currently receiving direct therapeutic mental health support.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Bath
Bath
Rachel Hiller, 01225 383794, rmbh20@bath.ac.uk
Rebecca Davis, 01225 383794, rsd52@bath.ac.uk
About this study
Official title: Addressing Elevated PTSD Symptoms in Young People in Care: A Randomised Feasibility Trial Across Social-care and Mental Health Services.
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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Teaching Recovery Techniques, Care as usual
- Keywords
- Post Traumatic Stress Disorder, PTSD, Trauma, Foster care, RCT, group
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching Recovery TechniquesBehavioural
Teaching Recovery Techniques is a 7-session group programme, with 5-sessions for the young person and 2-sessions for the carer. All sessions will be held online. The carer sessions are focused on psychoeducation around trauma and PTSD, as well as skills for supporting a young person through the intervention and with PTSD symptoms more broadly. The young person sessions are primarily focused on skill building and include: psychoeducation and understanding intrusive memories; intrusive images, worries and dreams; arousal, emotions, relaxation and coping; avoidance and triggers; and, memories.
Care as usualBehavioural
In the care as usual arm, social workers will follow their standard care protocol for young people experiencing psychological distress. A typical response may include a referral to either the specialist local CAMHS or general CAMHS.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receiving the Teaching Recovery Techniques intervention (delivered online). Receives: Behavioral: Teaching Recovery Techniques |
| Care-As-Usual Group | Active comparator | Receiving care-as-usual. Receives: Behavioral: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Aug 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic 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
- Participants will be randomised to either the online intervention group (Teaching Recovery Techniques) or the care-as-usual group. Any young people entering into the trial who live in the same household will be randomised together. If randomised to the TRT condition, each child will be offered participation in the next age-appropriate group.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of East Anglia, King's College London, University of Edinburgh, University of Bristol, Avon and Wiltshire Mental Health Partnership NHS Trust
- Responsible party
- Principal investigator, Sarah Halligan, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467320
- Sponsor's protocol ID
- 274914
- Acronym
- RELATE
- Status last verified
- Mar 2021
- First submitted
- 23 Jun 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hiller RM, Davis RS, Devaney J, Halligan SL, Meiser-Stedman R, Smith P, Stallard P, Kandiyali R, MacNeill S. Protocol for the RELATE trial: a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms. Pilot Feasibility Stud. 2021 Nov 13;7(1):204. doi: 10.1186/s40814-021-00936-7.
PubMed 34774093
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Elevated PTSD Symptoms in Young People in Care: A Randomised Feasibility Trial Across Social-care and Mental Health Services.
- ClinicalTrials.gov ID
- NCT04467320
- Acronym / sponsor ID
- RELATE / 274914
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder, PTSD, Trauma, Foster care, RCT, group
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of East Anglia, King's College London, University of Edinburgh, University of Bristol, Avon and Wiltshire Mental Health Partnership NHS Trust
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 13 Jul 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomised to either the online intervention group (Teaching Recovery Techniques) or the care-as-usual group. Any young people entering into the trial who live in the same household will be randomised together. If randomised to the TRT condition, each child will be offered participation in the next age-appropriate group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Teaching Recovery TechniquesReceiving the Teaching Recovery Techniques intervention (delivered online). |
| Care-As-Usual Group | Active comparator | Behavioral: Care as usualReceiving care-as-usual. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- A diagnosis of psychosis.
- Current and active serious suicidal ideations.
- A moderate to severe learning disability.
- Currently receiving direct therapeutic mental health support.
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 |
|---|---|---|
| Teaching Recovery TechniquesTeaching Recovery Techniques is a 7-session group programme, with 5-sessions for the young person and 2-sessions for the carer. All sessions will be held online. The carer sessions are focused on psychoeducation around trauma and PTSD, as well as skills for supporting a young person through the intervention and with PTSD symptoms more broadly. The young person sessions are primarily focused on skill building and include: psychoeducation and understanding intrusive memories; intrusive images, worries and dreams; arousal, emotions, relaxation and coping; avoidance and triggers; and, memories. | Behavioural | Intervention Group |
| Care as usualIn the care as usual arm, social workers will follow their standard care protocol for young people experiencing psychological distress. A typical response may include a referral to either the specialist local CAMHS or general CAMHS. | Behavioural | Care-As-Usual Group |
Primary outcome
Child and Adolescent Trauma Screen (CATS)
Time frame: 6 months
Self-report DSM-5 post-traumatic stress disorder (PTSD) symptom measure. Scores range from 0-60, with greater scores indicating greater symptom severity.
8 secondary outcomes
Child Revised Impact of Events Scale (CRIES-8)
Time frame: 6 months
Child PTSD Symptom Scale (CPSS-5) Interview Schedule
Time frame: 6 months
Inventory of Parent and Peer Attachment (IPPA)
Time frame: 6 months
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 6 months
Short Mood and Feelings Questionnaire (SMFQ)
Time frame: 6 months
Child Health Utility 9D (CHU9D)
Time frame: 6 months
Parent Trauma Response Questionnaire - support style subscale (PTRQ)
Time frame: 6 months
Child and Adolescent Trauma Screen (carer report)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 34774093Hiller RM, Davis RS, Devaney J, Halligan SL, Meiser-Stedman R, Smith P, Stallard P, Kandiyali R, MacNeill S. Protocol for the RELATE trial: a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms. Pilot Feasibility Stud. 2021 Nov 13;7(1):204. doi: 10.1186/s40814-021-00936-7.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching Recovery Techniques and Care as usual in people with Posttraumatic Stress Disorder, run by University of Bath at 1 site in United Kingdom.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Davis (07929827482, rsd52@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Adolescent Trauma Screen (CATS) (time frame: 6 months). 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 NCT04467320, which also lists 1 linked publication.
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 18 Mar 2021.