NCT03780088

Brief Summary

This study aims to evaluate the feasibility, effectiveness, and dissemination potential of an innovative strategy for improving access to effective sleep health care for adolescents. The study will test an adaptation of the Transdiagnostic Sleep and Circadian Intervention (TranS-C), a brief sleep intervention with demonstrated efficacy for improving sleep and mental health outcomes in youth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

January 16, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

December 17, 2018

Last Update Submit

August 13, 2021

Conditions

InsomniaDelayed Sleep Phase

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh Sleep Quality Index (PSQI)

    A validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality.

    baseline to end of treatment (anticipated average exposure 2 months), and month 5

Secondary Outcomes (2)

  • Patient Health Questionnaire 9 (PHQ-9)

    baseline to end of treatment (anticipated average exposure 2 months), and month 5

  • Strengths & Difficulties Questionnaire (SDQ)

    baseline and at months 2 and 5

Study Arms (1)

mTranS-C

EXPERIMENTAL

Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention

Behavioral: mTranS-C

Interventions

mTranS-CBEHAVIORAL

mobile health

mTranS-C

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 12-18 years
  • a sleep health deficit
  • youth has access to a mobile phone or internet
  • youth is fluent in English.

You may not qualify if:

  • current use of medications or herbs with known effects on sleep
  • current substance use disorder
  • current suicidality/thoughts of death
  • thought disorder
  • unstable major medical conditions
  • current psychotherapy for sleep health deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gardner Packard Children's Health Center

Atherton, California, 94027, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Lauren Asarnow, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 19, 2018

Study Start

January 16, 2019

Primary Completion

February 1, 2021

Study Completion

April 15, 2021

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)