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Investigating a Sleep Intervention for Adolescents Attending CAMHS

Primary Purpose

Insomnia, Mental Health Issue

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Strathclyde intervention to encourage good sleep health for teenagers (SIESTA)
Sponsored by
Stephanie McCrory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Adolescent Sleep, Insomnia, Mental Health, CBT-I

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ayrshire and Arran Child and Adolescent Mental Health Services

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm intervention group

Arm Description

Single-arm intervention

Outcomes

Primary Outcome Measures

Number of participants recruited and rates of retention
How many participants have been referred, consented and recruited overall. How many participants have dropped out.
Number of participants who attend each session
Measured through attendance logs. How many participants attended the sessions, number of non-attendance.
Staff satisfaction with training
Measured through qualitative interviews
Intervention fidelity
An intervention delivery checklist will be used by the researchers to assess the adherence to the SIESTA Delivery protocol.
Number of participant who adhere to components of intervention.
Captured through sleep diaries.

Secondary Outcome Measures

Acceptability of intervention to participants
Measured through qualitative interviews
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
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.
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).
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).
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).
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.

Full Information

First Posted
April 24, 2023
Last Updated
October 4, 2023
Sponsor
Stephanie McCrory
Collaborators
NHS Ayrshire and Arran
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1. Study Identification

Unique Protocol Identification Number
NCT05870228
Brief Title
Investigating a Sleep Intervention for Adolescents Attending CAMHS
Official Title
Investigating the Feasibility, Acceptability, and Preliminary Effectiveness of a Sleep Intervention for Adolescents With Co-morbid Insomnia and Mental Health Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephanie McCrory
Collaborators
NHS Ayrshire and Arran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Mental Health Issue
Keywords
Adolescent Sleep, Insomnia, Mental Health, CBT-I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-arm intervention group
Arm Type
Other
Arm Description
Single-arm intervention
Intervention Type
Behavioral
Intervention Name(s)
Strathclyde intervention to encourage good sleep health for teenagers (SIESTA)
Intervention Description
Group CBT-I
Primary Outcome Measure Information:
Title
Number of participants recruited and rates of retention
Description
How many participants have been referred, consented and recruited overall. How many participants have dropped out.
Time Frame
From participant referral to study completion (up to 1 year)
Title
Number of participants who attend each session
Description
Measured through attendance logs. How many participants attended the sessions, number of non-attendance.
Time Frame
From participant consent to study completion (up to 1 year)
Title
Staff satisfaction with training
Description
Measured through qualitative interviews
Time Frame
Post-intervention (up to 3 weeks)
Title
Intervention fidelity
Description
An intervention delivery checklist will be used by the researchers to assess the adherence to the SIESTA Delivery protocol.
Time Frame
Through intervention delivery, up to 6 months
Title
Number of participant who adhere to components of intervention.
Description
Captured through sleep diaries.
Time Frame
Through intervention delivery, up to 6 months
Secondary Outcome Measure Information:
Title
Acceptability of intervention to participants
Description
Measured through qualitative interviews
Time Frame
Post-intervention (up to 3 weeks)
Title
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)
Description
Captured through consensus sleep diary
Time Frame
Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Title
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)
Description
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.
Time Frame
Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Title
Depression and anxiety symptoms assessed by RCADS-25 (change from baseline, post-intervention and follow-up)
Description
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).
Time Frame
Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Title
Anxiety symptoms measured by GAD-7 (change from baseline, post-intervention and follow-up)
Description
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).
Time Frame
Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Title
Depression symptoms measured by PHQ-9 (change from baseline, post-intervention and follow-up)
Description
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).
Time Frame
Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Title
Circadian Phase Preference measured by MESC
Description
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.
Time Frame
Baseline only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie McCrory
Phone
0141 552 4400
Email
stephanie.mccrory@strath.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Fleming, PhD
Organizational Affiliation
University of Strathclyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayrshire and Arran Child and Adolescent Mental Health Services
City
Irvine
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigating a Sleep Intervention for Adolescents Attending CAMHS

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