Recruiting

Observational Study

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06139861

Conditions

Depression in Adolescence

Delayed Sleep Phase

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

TranS-C

Psychoeducation

Study Details

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.

Conditions

Depression in Adolescence

Delayed Sleep Phase

Study ID

NCT06139861

Start date

Mar 15, 2024

Status verified date

May, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TranS-C

active comparator: Psychoeducation

Interventions

TranS-C

Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.

Psychoeducation

The overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.

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) ]
  • 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 ]

Central Contacts and Locations

Central contacts

Lauren Asarnow, PhD

323-361-2471lasarnow@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Lauren Asarnow, PhD

323-361-2471lasarnow@chla.usc.edu

Principal Investigator:

Lauren Asarnow, PhD

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • Depression
  • Adolescents
  • Sleep
  • Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2026-05-11.