Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in Children and Young People

  • STATUS
    Recruiting
  • participants needed
    8
  • sponsor
    Royal Holloway University
Send
Updated on 9 December 2021
See if I qualify

Summary

Loneliness is a significant problem for young people and is associated with a range of physical and mental health difficulties. Meta-analyses have identified that interventions aimed at young people who report loneliness as their primary problem are lacking within the literature. In adults, the most effective interventions for loneliness are those which target the underlying maladaptive social cognitions. Therefore, the investigators have developed a modular Cognitive Behavioural Therapy (CBT) intervention for children and young people aiming to reduce their feelings of loneliness. The aim of this study is to conduct a multiple baseline single-case experimental design (SCED) to assess the efficacy, feasibility and acceptability of this intervention. In total 6-8 11-18-year-olds and their families will be recruited. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. Participants will complete a baseline assessment, before being randomised to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). Participants will then complete an average of 12 sessions of CBT, with the aim being to reduce their feelings of loneliness over 12 weeks. Participants will then complete a 12-day post-intervention phase. Participant loneliness will be repeatedly assessed throughout the three phases of the intervention using the Three-item Loneliness Scale, which will be the primary outcome. Secondary outcomes will be reliable and clinically meaningful change on the UCLA-LS-3, RCADS and SDQ. Feasibility and participant satisfaction will also be assessed and reported.

Description

The efficacy of CBT for loneliness in children and young people will be evaluated through a randomised multiple-baseline single case experimental design. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. In the SCED approach participants are repeatedly assessed on at least one independent variable, in this case self-reported loneliness on the Three-item Loneliness Scale, across each phase of the intervention. This repeated measurement and within subject replication is then used to test the effects of the intervention for individual participants.
The construction of this SCED trial and the reporting of the results will be in accordance with the Single-Case Reporting Guidelines in Behavioural Intervention (SCRIBE).
Participants will be recruited via advertisements emailed to schools, shared via social media and word of mouth. After consenting, participants and their parents/carers will complete a baseline eligibility assessment. Participants will complete a range of online questionnaires via a secure online platform. Participants will then attend a remote research assessment appointment to determine whether the family meet the eligibility criteria. The researcher completing the baseline and post-intervention assessments will not be involved in the clinical intervention and will be blinded to baseline allocation. After all baseline assessments for the participant group are completed, participants will be discussed within supervision to confirm that the participants meet eligibility criteria. Eligible participants will then be randomised using a random number generator to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). The decision to have a minimum of 12 observations per phase meets the requirements for guidelines and standards and will allow for sufficient power for Tau-U analysis.
Each of the participating families will then be contacted to inform them of their allocation. Randomisation and contacting of the families will be completed by a third researcher, who is not involved in either the clinical intervention or research assessments. A letter will also be sent to the participants General Practitioner (GP) informing them of the family's participation in the research study. The setting for the entire study will be remote, with both assessments and intervention sessions being conducted remotely a secure video platform.
All participants in the group will begin their baseline phase concurrently. During the baseline phase participants will be asked to complete the Three-Item Loneliness Scale each day via a secure online platform. SMS message reminders will also be sent to the participants and their parent/carers each day.
The baselines phase will be immediately followed by the intervention. Each family will receive (on average) 12 sessions of CBT for loneliness in children and young people. The first 4 sessions will take place bi-weekly, the second 4 sessions weekly and the final 4 sessions fortnightly.
For all participants the first two sessions will be focussed on assessment and then formulation. The final session for all participants will focus on relapse prevention. During the assessment session the participant will be asked to define 3 goal-based outcomes for how participants hope the intervention will reduce their loneliness, which will then guide the treatment process. During the intervention phase the participants will complete routine outcome measures (ROMs) for each session. This will include the Three-Item Loneliness Scale, visual analogue scales (VAS) of mood, anxiety and loneliness and ratings of their goal-based outcomes. The ROMs will be completed via a secure online platform before each session. If participants have not completed the ROMs before their appointment, then participants will be completed with the clinician at the start of the session.
Participants will begin the post-intervention phase immediately after the final session of their intervention. During the post-intervention phase participants will be asked to complete the primary outcome measure, Three-Item Loneliness Scale each day for 12 days. Participants will then complete their post-intervention assessment with the second researcher. Before the assessment participants will be asked to re-complete the baseline questionnaires in addition to the parent and child-report versions of the Experience of Service Questionnaire and a questionnaire asking whether COVID-19 or any other events have affected their loneliness during the intervention period. A letter will be sent to the participants General Practitioner (GP) informing them of their participation in the research study has finished.

Details
Condition Loneliness
Age 11years - 18years
Treatment Cognitive Behavioural Therapy (CBT) for Chronic Loneliness
Clinical Study IdentifierNCT05149963
SponsorRoyal Holloway University
Last Modified on9 December 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Be aged 11-18
Score more than 42 on the UCLA-LS-3 (Russel, 1996), which is more than one standard deviation above the mean in a large community adolescent sample (Shevlin, 2015)
Have a parent/carer who is willing to take part in the study
Report loneliness as their primary difficulty (i.e., they are able to identify relevant goal-based outcomes and their current difficulties are not attributable to a significant mental health problem)

Exclusion Criteria

Currently receiving psychological therapy
Started taking antidepressant in the last 8 weeks
Eligibility assessment indicates a severe mental health problem not considered suitable for the trial intervention due to the clinical need for immediate intervention, e.g., active suicidality and psychosis
Refusal for therapy sessions to be video recorded
Having an intellectual disability at a level whereby they cannot access the intervention
Do not have access to a laptop or smartphone which they can use for video calls
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.