SleepNCT02463188
Promoting Sleep to Prevent Substance Use in Adolescence
A study testing Sleep Fitness Intervention in people with Sleep and Substance Use, run by University of California, Berkeley at 1 site in United States.
Trial summary
The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Substance Use
- What is being tested?
- Sleep Fitness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Schools: Only general education high schools, not "newcomer" schools that target immigrants with limited English ability. Our rationale is that we need students to read and understand English well enough to complete our study measures and understand the intervention.
- Classes: After the selection of schools, we will select classes that are representative of the school, insofar as they do not reflect Advanced Placement or remedial classes and utilize similar criteria for admission to the classes (e.g. health, advisory) so that we minimize differences between the classes in the study.
- Students: All participants must receive parental consent, provide their own consent, and must have sufficient English language ability
Who cannot join
- We propose no exclusion criteria for students who receive parental consent, provide their own assent, and have sufficient English language ability.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Berkeley
Berkeley, California, 94720-1650
About this study
The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.
Read the detailed description
The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.
The investigators aim to conduct a pilot feasibility randomized controlled trial (RCT) among adolescents (n = 300) who will be randomized to Sleep Fitness (SF) or Sleep Education (SE) to obtain effect size estimates in preparation for a larger scale intervention study. This pilot trial is designed to obtain preliminary data for the following hypotheses:
SF, compared to SE, will produce greater pre-post improvement in sleep after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
SF, compared to SE, will produce greater pre-post reductions in substance use after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
SF, compared to SE, will produce greater pre-post improvement on selected mental health outcomes (anxiety, depression) after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
- Conditions
- Sleep, Substance Use
- Being tested
- Sleep Fitness Intervention
- Keywords
- Sleep, Substance Use, Adolescents
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Fitness InterventionBehavioural
The intervention consists of 5-7 sessions. Each session includes interactive and small group discussions. The intervention also includes lessons on sleep science, behavior change strategies, and one-on-one motivational interviews on behavior change motivation.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Fitness Intervention | Experimental | The intervention consists of 5-7 sessions on sleep science, the connection between sleep and substance use, behavior change strategies, and motivation to change behavior. Receives: Behavioral: Sleep Fitness Intervention |
| Psychoeducation (PE) | No intervention | The control classes will receive an 1-session psycho-educational (PE) intervention that provides information on sleep but does not provide guidance for implementing behavior change and does not explicitly teach about sleep's relationship to substance use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Sleep
Sleep Diary 1 Week: Total sleep time (Average of weeknights)
Measured: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Primary Substance Use
Measures from Monitoring the Future: 30-day use
Measured: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Secondary outcomes (2)
Depressive Symptoms
Center for Epidemiologic Studies- Depression
Measured: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Anxiety Symptoms
Revised Children's Manifest Anxiety Scale
Measured: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startFeb 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Harvey, PhD, Principal investigator, University of California, BerkeleyEmily Ozer, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463188
- Sponsor's protocol ID
- 5R34DA035349-02
- Status last verified
- Jul 2017
- First submitted
- 26 May 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Sleep to Prevent Substance Use in Adolescence
- ClinicalTrials.gov ID
- NCT02463188
- Acronym / sponsor ID
- 5R34DA035349-02
- Conditions
- Sleep, Substance Use
- Keywords
- Sleep, Substance Use, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.
Detailed description
The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.
The investigators aim to conduct a pilot feasibility randomized controlled trial (RCT) among adolescents (n = 300) who will be randomized to Sleep Fitness (SF) or Sleep Education (SE) to obtain effect size estimates in preparation for a larger scale intervention study. This pilot trial is designed to obtain preliminary data for the following hypotheses:
SF, compared to SE, will produce greater pre-post improvement in sleep after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
SF, compared to SE, will produce greater pre-post reductions in substance use after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
SF, compared to SE, will produce greater pre-post improvement on selected mental health outcomes (anxiety, depression) after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Fitness Intervention | Experimental | Behavioral: Sleep Fitness InterventionThe intervention consists of 5-7 sessions on sleep science, the connection between sleep and substance use, behavior change strategies, and motivation to change behavior. |
| Psychoeducation (PE) | No intervention | –The control classes will receive an 1-session psycho-educational (PE) intervention that provides information on sleep but does not provide guidance for implementing behavior change and does not explicitly teach about sleep's relationship to substance use. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Schools: Only general education high schools, not "newcomer" schools that target immigrants with limited English ability. Our rationale is that we need students to read and understand English well enough to complete our study measures and understand the intervention.
- Classes: After the selection of schools, we will select classes that are representative of the school, insofar as they do not reflect Advanced Placement or remedial classes and utilize similar criteria for admission to the classes (e.g. health, advisory) so that we minimize differences between the classes in the study.
- Students: All participants must receive parental consent, provide their own consent, and must have sufficient English language ability
Key exclusion criteria (1 listed)
- We propose no exclusion criteria for students who receive parental consent, provide their own assent, and have sufficient English language ability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Fitness InterventionThe intervention consists of 5-7 sessions. Each session includes interactive and small group discussions. The intervention also includes lessons on sleep science, behavior change strategies, and one-on-one motivational interviews on behavior change motivation. | Behavioural | Sleep Fitness Intervention |
Primary outcome
Primary Sleep
Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Sleep Diary 1 Week: Total sleep time (Average of weeknights)
Primary Substance Use
Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Measures from Monitoring the Future: 30-day use
2 secondary outcomes
Depressive Symptoms
Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Anxiety Symptoms
Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Harvey, PhD principal investigator
University of California, Berkeley
Emily Ozer, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Fitness Intervention in people with Sleep and Substance Use, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Sleep (time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.