Better Sleep Study | NCT06139861

Studies
Better Sleep Study

NCT06139861

Sponsor

Children's Hospital Los Angeles

Status

Recruiting

Last Update Posted

May 11, 2026Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Depression in Adolescence
Delayed Sleep Phase

Interventions

TranS-C
Psychoeducation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH129558-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2024Actual

Primary Completion Date

Aug 1, 2028Estimated

Completion Date

Aug 1, 2028Estimated

First Submitted Date

Nov 14, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2026

Last Update Posted Date

May 11, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lauren Asarnow, Medical Staff/USC Faculty CWR Neurology, Children's Hospital Los AngelesPrincipal Investigator

Lead Sponsor

Children's Hospital Los AngelesOTHER

Collaborators

Name	Class
Stanford University	OTHER
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TranS-C	Experimental		Behavioral: TranS-C
Psychoeducation	Active Comparator		Behavioral: Psychoeducation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TranS-C	Behavioral	Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.	TranS-C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lauren Asarnow, PhD	Contact	323-361-2471		lasarnow@chla.usc.edu

Overall Officials

Name	Affiliation	Role
Lauren M Asarnow, PhD	Children's Hospital Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Los Angeles	Recruiting	Los Angeles	California	90027	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided