The study is a two-arm randomised controlled trial conducted in secondary schools in the United Kingdom (UK). The experimental arm is Online Social anxiety Cognitive therapy for Adolescents (OSCA). The comparison arm is waitlist. All participants will be assessed three times: at baseline (pretreatment/wait), midtreatment/wait (week 8), posttreatment/wait (week 15). Participants in the experimental arm will also be assessed at 3- and 6-month follow-up. Postwait, participants in the waitlist arm will be offered OSCA. Assessments will be undertaken with parents as well where possible. Fig. 1 shows the trial flow diagram. The trial has received approval from the University of Oxford Medical Sciences Division Research Board and it has been prospectively registered (http://www.isrctn.com/ISRCTN15079139).
The basic trial methods of enrolment, interventions, and assessments are summarised in Fig. 2. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist is provided as Additional File 1.
A total of 40 adolescents aged between 14-18 years at intake with a diagnosis of SAD will be included. DSM-5 diagnosis will be determined by the Anxiety Disorders Interview Schedule for children and parents . Only adolescents for whom SAD is the primary problem will be included. All participants must be able to read and write in English, due to the nature of the therapy and the need to complete self-report questionnaires.
Young people who are currently receiving any other psychological intervention or who have previously received Cognitive Therapy or CBT for SAD will not be invited to take part. Other exclusion criteria include: the presence of an autism spectrum disorder; learning disability; current alcohol or substance dependence; presence or suspected presence of psychosis; suicidal intent or recurrent self-harming behaviour; and young people identified by social services as currently ‘at risk’ due to child protection concerns.
Sample size was estimated from an RCT of adolescents with SAD comparing a version of face-to-face Cognitive Therapy with attention placebo (Ingul, Aune, & Nordahl, 2014). The comparison effect size posttreatment was 1.26. A recent adult RCT by our group suggests outcomes for face-to-face and Internet-delivered Cognitive Therapy are similar. Based on a conservative estimate of the effect of 1.0, we would need 17 per group for 80% power. The sample size was inflated to allow for drop out following randomisation , resulting in a final sample size of 40.
Recruitment and randomisation
Participants will be recruited via secondary schools. The use of schools as a referral source has two advantages. It will ensure adolescents with a range of symptom severity will be included and it fits with potential future delivery mechanisms for the treatment, should efficacy be demonstrated.
For the screening stage, during class time in school, young people will be asked to complete the Mini-SPIN  and to indicate whether or not they would like to learn more about the study. The Mini-SPIN is a three-item questionnaire that is sensitive and specific to SAD in adults  and adolescents . We were guided in how best to recruit participants in a non-stigmatising way in consultation with school students. Prior to initiating recruitment in schools we will send information out to parents informing them of the project and providing details of what will be happening in their child’s school.
The process of seeking informed consent will differ for 14 to 15 year olds and 16 to 18 year olds. This is because 16 to 18 year olds will be treated as ‘competent youth’ for the purposes of this study. For 14 to 15 year olds, information about the study will be provided to the young person after parental consent has been obtained. For 16-18 year olds, information about the study will be provided to the young person directly, without seeking parental consent first. At least 24 hours after information has been given to the young person, a meeting will be scheduled during school hours. At this meeting written assent/consent will be sought. Once written assent/consent has been obtained, the full pre-intervention assessment will be completed. This will involve ensuring all eligibility criteria are met. For 16-18 year olds, we will also seek their agreement to contact parents in order to inform them of their child’s involvement in the project.
Adolescents meeting inclusion criteria and not meeting any exclusion criteria will be randomised to waitlist or treatment. Adolescents not eligible to take part after the parent and young person assessments will be supported in accessing help via alternative means (if they would like this). Eligible participants will be randomly allocated to OSCA or waitlist. Individual randomisation will be conducted using an online minimisation algorithm generated by the trial statistician. The ratio will be 1:1. Minimisation will ensure balance between trial arms for gender, but will retain a random element and will be stratified by severity. Randomisation will occur after consent has been taken and baseline measures have been completed. It will be done by the Oxford Cognitive Health and Neuroscience Clinical Trials Unit. The trial team will email details of the stratification variables to the independent statistician who will then randomise the participant. Following randomisation, participants will be notified of their allocation.
The Online Social anxiety Cognitive therapy for Adolescents (OSCA) uses the same Internet platform as the adult programme with minor adaptations. We undertook a small study in which five young people (aged 16-18y) worked through the adult online programme and then provided their feedback and suggestions for adaptations for adolescents. The programme was well received, and only minor adaptations were suggested. Specifically, the young people suggested that some video clips be re-filmed with young actors and that the case examples were relevant to young people (e.g. describing adolescent-relevant situations, such as being at school and seeing friends, rather than being at work).
The OSCA program takes 14 weeks. All users receive a core set of modules to work through at the beginning of the programme. The programme is then individualised for each user. The therapist releases modules that will be most helpful to that person, depending on their particular concerns. Adolescents complete OSCA modules at home and they can logon as often as they like. During the 14 weeks of treatment, young people allocated to OSCA will have a 15-minute phone conversation with their therapist each week, in line with procedures in the adult treatment trial (Clark et al., in prep). The telephone call is to support and encourage young people and to ensure that they are given access to all of the parts of the program that are most helpful to them. In addition, they will receive regular encouragement and support via secure messaging within the online programme and SMS texts.
We will seek to keep all parents updated on their child’s progress in treatment. This will be explained to children aged 14-15 years. Consent for this will be sought from young people aged 16-18 years. Parental involvement will involve regular emails with a short general summary of therapy modules.
The only contact with participants in the waitlist arm during the wait period will be at the midwait time point, when they are requested to complete outcome measures. Participants in the waitlist arm will be offered treatment with OSCA after the postwait assessment.
One of the benefits of Internet treatments is their high fidelity . The therapist (EL) was involved in the development of Cognitive Therapy for SAD in adolescents. Throughout the trial they will receive supervision from the developer of the cognitive model of SAD, the face-to-face and Internet versions of Cognitive Therapy for SAD, and the version for adolescents (DMC).
Primary Outcome Measures
The primary outcomes will be: changes on the self-report version of the Liebowitz Social Anxiety Scale for Children and Adolescents- Self-report Version (LSAS-CA-SR) , and recovery from SAD. To assess recovery, the proportion of adolescents who continue to meet DSM-5 diagnostic criteria for SAD at posttreatment/wait will be examined. Diagnosis will be made using The Anxiety Disorders Interview Schedule IV for Children and Parents (ADIS-C/P) . All participants will be interviewed with the child version and parents will be interviewed where possible. Participants who withdraw from the study will also be invited to complete the assessments. Assessments will be completed face-to-face or over the telephone by trained assessors. See Fig. 3. for timings of outcome measures.
Secondary Outcome Measures
As secondary outcomes, changes on a measure of aspects of social anxiety (the Social Phobia Weekly Summary Scale ), general anxiety as measured by the Revised Child Anxiety & Depression Scale (RCADS, self-report [and parent report where possible]; Chorpita, Yim ), and depression as measured with the Short Mood and Feelings Questionnaire (SMFQ; Angold, Costello ) will be examined. Social functioning (including social satisfaction, friendship quality, and peer victimization) will be assessed by self-report questionnaire and school functioning will be captured through % attendance and grade average (either internal or external examination scores or grade estimate). Self-reported ability to concentrate in class will be measured . See Fig. 3. for timings of outcome measures.
The following measures of possible mediators of therapeutic improvement will be used: the Adolescent Social Cognitions Questionnaire (ASCQ); Adolescent Social Behaviours Questionnaire (ASBQ); and Adolescent Social Attitudes Questionnaire (ASAQ). These three measures were all adapted for adolescents by the authors from versions developed for socially anxious adults .
Measure of alliance and treatment credibility and acceptability
The quality of the therapeutic relationship, as perceived by both the therapist and the participants, will be assessed with the shortened Working Alliance Inventory  as a potential predictor of outcome. Participants will rate treatment credibility with the Credibility of Therapy Scale  as another potential predictor of outcome. Feedback questionnaires will be completed posttreatment to assess the acceptability of the treatment.
Blinding of therapists and participants is not possible due to the nature of the design. However, assessments will be carried out by independent raters who are blind to allocation. The independent raters will be psychology graduates or above. All will have received training in the use of the outcome assessment. All will have demonstrated reliability in administration of the ADIS-C/P.
Data completeness and monitoring
In our adult trials of Cognitive Therapy, data completeness has always been above 95%. Methods to enhance data completeness that we will adopt include the use of session-by-session outcome monitoring (so if someone drops out early the last available symptom measure can be used) and weekly outcome-measure informed supervision. As a Phase I trial, a Data Management Committee was not considered to be necessary. As such, the trial team is responsible for monitoring and management of the data. Data will be monitored for completeness, consistency, and plausibility by the trial statistician. The trial team and statistician will have full access to the final trial dataset. The study data will be reported in line with current CONSORT guidelines.
All analyses will be intent-to-treat. No interim analyses are planned. Outcomes will be compared with hierarchical linear modelling. Time (midwait/midtreatment, and postwait/posttreatment), treatment condition (OSCA, waitlist), and the time x condition interaction will be specified as categorical fixed factors, with baseline LSAS and gender as fixed covariates, and participant as a random effect to account for between-person variation. Exploratory analyses using linear mixed effects models for each step to account for the nested data structure  will test for mediation of OSCA on social anxiety symptoms at posttreatment through candidate process variables from the cognitive model. Baseline outcomes will be included as predictors in all models. Categorical outcomes (response, remission, deterioration, and diagnostic status) will be analysed using logistic regression, with treatment condition as the independent variable, and baseline LSAS score and gender as covariates.
Potential risks to the participant are minimal. There is potential for inconvenience because the young person is invited to take part in a treatment that will involve a time commitment. The potential for inconvenience will be minimised by virtue of the online nature of the treatment: young people can decide when and where is most convenient for them to complete treatment modules. Young people are free to withdraw from the study at any time.
In principle, there is potential for distress while completing OSCA. The likelihood of this is low because the program is goal-oriented in nature; young people did not become upset receiving the treatment in our previous case series. We will minimise this risk by fully explaining the nature of the program to young people. The young person is free to withdraw from the project at any time. In our pilot case series none of the adolescents who were treated showed an overall deterioration in their symptoms. Instead, everyone showed some benefit. This is consistent with the findings from our adult trials. We therefore consider the risk of symptom exacerbation to be low. Weekly measures of social anxiety and depressed mood will be taken and so any signs of deterioration will be detected quickly in the unlikely event that this should occur. An item assessing risk to self will be inserted into the SMFQ from the long version of the scale (item 19). Scores on this item will be reviewed weekly by the therapist to monitor levels and changes in risk. If signs of deterioration or an elevation in risk are identified, then the young person will be contacted and the appropriate procedures will be followed. An aim of the OSCA trial is to examine the safety of the treatment. We will do this in two ways. Adverse events (any untoward occurrence in an individual to whom the intervention has been administered including occurrences which are not necessarily caused by or related to that therapy) will be monitored and recorded from randomisation to the final follow-up at 6-months. We will also assess reliable deterioration on the LSAS-CA-SR (our primary outcome measure).
Half of the participants will be randomly allocated to the waitlist condition. During this 14-week period the only contact they will have with the research team is at the midwait stage when they will be asked to complete questionnaires. It is possible that participants in the waitlist condition will require treatment during this period. Participants and their parents will be advised that they should seek services and help as required.
The online treatment programme has numerous security features representing current best practice and complies with NHS data security standards. It employs secure client-server communication, full encryption of the server database, enforcement of strong passwords, two- factor authentication and hosting on a tier 4 hosting server. External access to database using SSH protocol is prohibited. The system has been subjected to industry-standard penetration testing. Online data is secured by encryption to prevent access from outside parties. The software company hosting the online therapy programmes (FRY-IT) access to the server data is protected by non-disclosure agreements and the Data Protection Act (1998).
Service User Involvement
Young people, both healthy school pupils and service users, have been involved in all stages of the project. Service users have been involved in the development of the questionnaires and the worksheets used to support face-to-face Cognitive Therapy and OSCA. Young people have provided detailed advice on how to adapt adult online Cognitive Therapy for young people. Pupils have advised on how best to recruit young people in schools. A small group of young people have requested to remain involved in a consultation role throughout the trial.