Clinical trial NCT04467320: Recovery Learning for Adolescents After Traumatic Experiences
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
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Post Traumatic Stress Disorder
PTSD
Trauma
Foster care
RCT
group
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of East Anglia
name: King's College London
name: University of Edinburgh
name: University of Bristol
name: Avon and Wiltshire Mental Health Partnership NHS Trust
First posted: 2020-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Child and Adolescent Trauma Screen (CATS)
timeFrame: 6 months
Secondary outcomes:
measure: Child Revised Impact of Events Scale (CRIES-8)
timeFrame: 6 months
measure: Child PTSD Symptom Scale (CPSS-5) Interview Schedule
timeFrame: 6 months
measure: Inventory of Parent and Peer Attachment (IPPA)
timeFrame: 6 months
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 6 months
measure: Short Mood and Feelings Questionnaire (SMFQ)
timeFrame: 6 months
measure: Child Health Utility 9D (CHU9D)
timeFrame: 6 months
measure: Parent Trauma Response Questionnaire - support style subscale (PTRQ)
timeFrame: 6 months
measure: Child and Adolescent Trauma Screen (carer report)
timeFrame: 6 months
Other outcomes:
measure: Focus groups and 1:1 semi-structured interviews
timeFrame: 2 months
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
Study officials:
References:
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.