Recovery Learning for Adolescents After Traumatic Experiences (RELATE)

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.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Teaching Recovery Techniques; Behavioral: Care as usual

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Davis; Phone Number: 07929827482; Email: rsd52@bath.ac.uk

Study Locations

• United Kingdom
  • Bath, United Kingdom
    • Recruiting
    • University of Bath
    • Contact: Rachel Hiller; Phone Number: 01225 383794; Email: rmbh20@bath.ac.uk
    • Contact: Rebecca Davis; Phone Number: 01225 383794; Email: rsd52@bath.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Receiving the Teaching Recovery Techniques intervention (delivered online).	Behavioral: Teaching Recovery Techniques; 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.
Active Comparator: Care-As-Usual Group; Receiving care-as-usual.	Behavioral: Care as usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Focus groups and 1:1 semi-structured interviews	Qualitative measures carried out with young people, carers and service providers	2 months

Collaborators and Investigators

• Sponsor: University of Bath
• Collaborators: King's College London; University of Bristol; University of Edinburgh; University of East Anglia; National Institute for Health Research, United Kingdom; Avon and Wiltshire Mental Health Partnership NHS Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; RCT; Trauma; Post Traumatic Stress Disorder; Foster care; group
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 274914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No