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Recovery Learning for Adolescents After Traumatic Experiences (RELATE)

Primary Purpose

Posttraumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Teaching Recovery Techniques
Care as usual
Sponsored by
University of Bath
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, PTSD, Trauma, Foster care, RCT, group

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of BathRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Care-As-Usual Group

Arm Description

Receiving the Teaching Recovery Techniques intervention (delivered online).

Receiving care-as-usual.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 23, 2020
Last Updated
March 16, 2021
Sponsor
University of Bath
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
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1. Study Identification

Unique Protocol Identification Number
NCT04467320
Brief Title
Recovery Learning for Adolescents After Traumatic Experiences
Acronym
RELATE
Official Title
Addressing Elevated PTSD Symptoms in Young People in Care: A Randomised Feasibility Trial Across Social-care and Mental Health Services.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Post Traumatic Stress Disorder, PTSD, Trauma, Foster care, RCT, group

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Receiving the Teaching Recovery Techniques intervention (delivered online).
Arm Title
Care-As-Usual Group
Arm Type
Active Comparator
Arm Description
Receiving care-as-usual.
Intervention Type
Behavioral
Intervention Name(s)
Teaching Recovery Techniques
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Care as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child and Adolescent Trauma Screen (CATS)
Description
Self-report DSM-5 post-traumatic stress disorder (PTSD) symptom measure. Scores range from 0-60, with greater scores indicating greater symptom severity.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Child Revised Impact of Events Scale (CRIES-8)
Description
Self-report post-traumatic stress disorder (PTSD) symptom screening tool. Symptom scores range from 0-40, with higher scores indicating greater symptom severity.
Time Frame
6 months
Title
Child PTSD Symptom Scale (CPSS-5) Interview Schedule
Description
DSM-5 PTSD diagnostic interview. Symptoms range from 0-80, with higher scores indicating greater symptom severity.
Time Frame
6 months
Title
Inventory of Parent and Peer Attachment (IPPA)
Description
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.
Time Frame
6 months
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
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.
Time Frame
6 months
Title
Short Mood and Feelings Questionnaire (SMFQ)
Description
Self-report and carer-report depression questionnaire. Scores range from 0-26, with higher scores indicating more depressive symptoms.
Time Frame
6 months
Title
Child Health Utility 9D (CHU9D)
Description
Self-report measure of health-related quality of life. Scores range from 9-45, with higher scores indicating greater difficulties.
Time Frame
6 months
Title
Parent Trauma Response Questionnaire - support style subscale (PTRQ)
Description
Carer-report measure of their support style. Scores range from 0-30, with higher scores indicating greater difficulties.
Time Frame
6 months
Title
Child and Adolescent Trauma Screen (carer report)
Description
Carer-report young person PTSD symptom scale. Symptom scores range from 0-60, with higher scores indicating greater symptom severity.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Focus groups and 1:1 semi-structured interviews
Description
Qualitative measures carried out with young people, carers and service providers
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Davis
Phone
07929827482
Email
rsd52@bath.ac.uk
Facility Information:
Facility Name
University of Bath
City
Bath
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Hiller
Phone
01225 383794
Email
rmbh20@bath.ac.uk
First Name & Middle Initial & Last Name & Degree
Rebecca Davis
Phone
01225 383794
Email
rsd52@bath.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34774093
Citation
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.
Results Reference
derived

Learn more about this trial

Recovery Learning for Adolescents After Traumatic Experiences

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