Investigating a Sleep Intervention for Adolescents Attending CAMHS

Study Overview
=================
Brief Summary
-----------------
The overall objectives of the study are to: To assess the feasibility of delivering the Strathclyde intervention to encourage good sleep health for teenagers (SIESTA) to adolescents with co-morbid insomnia and mental health attending Child and Adolescent Mental Health Services. The following feasibility benchmarks will be assessed: recruitment and retention, participant attendance, staff training, intervention fidelity and participant adherence. To examine participant acceptability. The researchers will conduct qualitative interviews with the participants and delivery staff to examine the acceptability of the programme. To investigate the preliminary effectiveness by assessing the following: sleep parameters, insomnia symptoms, Circadian phase preference (baseline only) and mental health symptoms. Data will be collected at baseline, post-intervention and 3 month follow-up.

Detailed Description
-----------------
Sleep problems have a significant detrimental impact on physical health, development, and functioning and are commonly experienced co-morbidly with other mental health problems. Therefore, many adolescents who are attending Child and Adolescent Mental Health Services (CAMHS), also experience significant sleep disturbances. However, sleep problems are rarely addressed within CAMHS due to lack of awareness of the importance of sleep and/or training in effective treatments. Cognitive behavioural therapy for insomnia (CBT-I) is the recommended approach for treating insomnia in both adult and adolescent populations. Despite this, there has been limited research investigating the delivery of CBT-I interventions to adolescents attending CAMHS, and to our knowledge, no such studies exist within the Scottish context. The Strathclyde intervention to encourage good sleep health for teenagers (SIESTA) incorporates CBT-I components to improve adolescent sleep. This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of SIESTA for adolescents attending CAMHS. Staff within CAMHS will receive training to deliver SIESTA to groups of adolescents with co-morbid mental health and sleep problems. The following feasibility benchmarks will be assessed: recruitment and retention, participant attendance, facilitator training, intervention fidelity and participant adherence. Acceptability will be measured via qualitative interviews with participants and CAMHS staff. Baseline, post-intervention, and follow-up assessments will be conducted to assess preliminary effectiveness of the intervention for improving sleep and mental health. This research is necessary to inform future trials of SIESTA and to support its wider implementation within CAMHS.

Official Title
-----------------
Investigating the Feasibility, Acceptability, and Preliminary Effectiveness of a Sleep Intervention for Adolescents With Co-morbid Insomnia and Mental Health Difficulties

Conditions
-----------------
Insomnia, Mental Health Issue

Intervention / Treatment
-----------------
* Behavioral: Strathclyde intervention to encourage good sleep health for teenagers (SIESTA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents (12-15 years) Meeting thresholds for insomnia disorder (determined by cut-off scores on the 2 item Sleep Condition Indicator (score <2 indicates probable insomnia) Attending CAMHS for mental health intervention/support Able to engage with intervention protocol Exclusion Criteria: Active suicide ideation and/or recent suicidal attempts Contraindicators for components of CBT-I (sleep restriction therapy) including seizure disorders/conditions including epilepsy, bipolar disorder, symptoms of psychosis, obstructive sleep apnea and parasomnias. Diagnosis of Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Foetal Alcohol Spectrum Disorder (Neurodiversity) Those who are currently completing, or have recently completed (in the past 6 months), CBT-I for insomnia elsewhere (or components of CBT-I including e.g. sleep restriction therapy, stimulus control, cognitive techniques). This will only include in-person, one-to-one methods of delivery

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm intervention group<br>Single-arm intervention | Behavioral: Strathclyde intervention to encourage good sleep health for teenagers (SIESTA)<br>* Group CBT-I<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recruited and rates of retention | How many participants have been referred, consented and recruited overall. How many participants have dropped out. | From participant referral to study completion (up to 1 year) | 
| Number of participants who attend each session | Measured through attendance logs. How many participants attended the sessions, number of non-attendance. | From participant consent to study completion (up to 1 year) | 
| Staff satisfaction with training | Measured through qualitative interviews | Post-intervention (up to 3 weeks) | 
| Intervention fidelity | An intervention delivery checklist will be used by the researchers to assess the adherence to the SIESTA Delivery protocol. | Through intervention delivery, up to 6 months | 
| Number of participant who adhere to components of intervention. | Captured through sleep diaries. | Through intervention delivery, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of intervention to participants | Measured through qualitative interviews | Post-intervention (up to 3 weeks) | 
| Sleep outcomes including sleep onset, total sleep time, total time in bed, wake after sleep onset, sleep efficiency (change from baseline, post-intervention and follow-up) | Captured through consensus sleep diary | Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery)) | 
| Insomnia symptoms assessed using SCI (<16 indicates probable insomnia, higher scores indicate better sleep, scores range 0-32) (change from baseline, post-intervention and follow-up) | Measured with the Sleep Condition Indicator (SCI) which measures symptoms of insomnia. The 8-item scale includes recommended cut-off score (<16) to indicate probable insomnia. | Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery)) | 
| Depression and anxiety symptoms assessed by RCADS-25 (change from baseline, post-intervention and follow-up) | Measured by Revised Child Anxiety and Depression Scale - 25 (RCADS-25). The 25-item scale measures symptoms of depression and anxiety using two sub-scales. Each sub-scale is calculated and then converted into a t-score. T-scores indicate levels of symptom severity including: <65 low severity, 65-70 medium severity (borderline clinical threshold), >70 high severity (clinical threshold). | Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery)) | 
| Anxiety symptoms measured by GAD-7 (change from baseline, post-intervention and follow-up) | Measured by Generalised Anxiety Disorder Assessment (GAD-7). The GAD-7 will be utilised to measure symptoms of anxiety. The measure consists of 7 items assessing anxiety symptoms over the previous 2 weeks. Scores range from 0-21, higher scores indicate greater symptom severity (5- mild, 10 - moderate, 15- severe). | Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery)) | 
| Depression symptoms measured by PHQ-9 (change from baseline, post-intervention and follow-up) | Measured by Patient Health Questionnaire-9 (PHQ-9). Scores range from 0-27 with higher scores indicating greater symptom severity (5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe). | Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery)) | 
| Circadian Phase Preference measured by MESC | Measured by Morningness/eveningness scale for children (MESC). This 10-item measure will be used to assess circadian phase preference. Items are scored on a 4 or 5 item scale and scores range from 10-42. Lower scores indicate greater eveningness and higher scores indicate greater morningness. This item will be collected in the baseline assessment. | Baseline only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent Sleep, Insomnia, Mental Health, CBT-I