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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2021
Source University of Bath
Contact Rebecca Davis
Phone 07929827482
Email rsd52@bath.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
United Kingdom University of Bath Bath

Sponsors (7)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

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
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