Depression in AdolescenceNCT06139861
Better Sleep Study
A study testing TranS-C and Psychoeducation in people with Depression in Adolescence and Delayed Sleep Phase, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression in Adolescence, Delayed Sleep Phase
- What is being tested?
- TranS-C and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; Bipolar Disorder; drug dependence
- severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer)
- current use of medications or herbs with known effects on sleep
- plan to undergo or have had medication change in the last 8 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Lauren Asarnow, PhD, 323-361-2471, lasarnow@chla.usc.edu
Lauren Asarnow, PhD
About this study
Official title: A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents
The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.
- Conditions
- Depression in Adolescence, Delayed Sleep Phase
- Being tested
- TranS-C, Psychoeducation
- Keywords
- Depression, Adolescents, Sleep, Intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranS-CBehavioural
Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.
PsychoeducationBehavioural
The overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.
| Study group | Role | What they receive |
|---|---|---|
| TranS-C | Experimental | Not described Receives: Behavioral: TranS-C |
| Psychoeducation | Active comparator | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )
Validated biological and behavioral assessment; range between 0 and 11 hours, with shorter numbers indicating worse alignment between circadian biology and behavior
Measured: baseline to end of treatment (0 and 2 months)
Change in Children's Depression Rating Scale (CDRS-R)
Validated clinician administered depression symptom severity scale; range between 17 and 133, with higher numbers indicative of greater depression severity
Measured: baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Mar 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lauren Asarnow, Children's Hospital Los Angeles
- Investigators
- Lauren M Asarnow, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139861
- Sponsor's protocol ID
- CHLA-25-00351
- Other IDs
- R01MH129558-01A1
- Status last verified
- May 2026
- First submitted
- 14 Nov 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents
- ClinicalTrials.gov ID
- NCT06139861
- Acronym / sponsor ID
- CHLA-25-00351
- Conditions
- Depression in Adolescence, Delayed Sleep Phase
- Keywords
- Depression, Adolescents, Sleep, Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Stanford University, National Institute of Mental Health (NIMH)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 18 Nov 2023 (actual)
- 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 overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TranS-C | Experimental | Behavioral: TranS-C |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; Bipolar Disorder; drug dependence
- severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer)
- current use of medications or herbs with known effects on sleep
- plan to undergo or have had medication change in the last 8 weeks
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 |
|---|---|---|
| TranS-CTransdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy. | Behavioural | TranS-C |
| PsychoeducationThe overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects. | Behavioural | Psychoeducation |
Primary outcome
Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )
Time frame: baseline to end of treatment (0 and 2 months)
Validated biological and behavioral assessment; range between 0 and 11 hours, with shorter numbers indicating worse alignment between circadian biology and behavior
Change in Children's Depression Rating Scale (CDRS-R)
Time frame: baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14
Validated clinician administered depression symptom severity scale; range between 17 and 133, with higher numbers indicative of greater depression severity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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.
Lauren M Asarnow, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TranS-C and Psychoeducation in people with Depression in Adolescence and Delayed Sleep Phase, run by Children's Hospital Los Angeles 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 0 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Asarnow, PhD (323-361-2471, lasarnow@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME ) (time frame: baseline to end of treatment (0 and 2 months)). 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 11 May 2026.