NCT04467320

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

June 23, 2020

Last Update Submit

March 16, 2021

Conditions

Keywords

Post Traumatic Stress DisorderPTSDTraumaFoster careRCTgroup

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Child Revised Impact of Events Scale (CRIES-8)

    6 months

  • Child PTSD Symptom Scale (CPSS-5) Interview Schedule

    6 months

  • Inventory of Parent and Peer Attachment (IPPA)

    6 months

  • Strengths and Difficulties Questionnaire (SDQ)

    6 months

  • Short Mood and Feelings Questionnaire (SMFQ)

    6 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Focus groups and 1:1 semi-structured interviews

    2 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Receiving the Teaching Recovery Techniques intervention (delivered online).

Behavioral: Teaching Recovery Techniques

Care-As-Usual Group

ACTIVE COMPARATOR

Receiving care-as-usual.

Behavioral: Care as usual

Interventions

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 Group
Care as usualBEHAVIORAL

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.

Care-As-Usual Group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • A diagnosis of psychosis.
  • Current and active serious suicidal ideations.
  • A moderate to severe learning disability.
  • Currently receiving direct therapeutic mental health support.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Rebecca Davis

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Child and Family Mental Health

Study Record Dates

First Submitted

June 23, 2020

First Posted

July 13, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations