The Reducing Risk Study

NCT ID: NCT03665337

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-08-01

Brief Summary

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The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.

Detailed Description

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Conditions

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Insomnia Delayed Sleep Phase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors

Study Groups

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mTranS-C

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

Group Type EXPERIMENTAL

mTranS-C

Intervention Type BEHAVIORAL

MOBILE HEALTH

Control

Access to a mobile and computer accessible control intervention that targets coping skills and sleep education.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

MOBILE HEALTH

Interventions

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mTranS-C

MOBILE HEALTH

Intervention Type BEHAVIORAL

Control

MOBILE HEALTH

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

* any current psychiatric illness
* currently use of medications or herbs with known effects on sleep
* hospitalization for substance use or suicide within the past 12 months
* known sleep apnea
* unstable major medical conditions
* current psychotherapy for depression, anxiety or sleep health deficits
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Asarnow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Asarnow, PhD

Role: CONTACT

(415) 476-7439

Facility Contacts

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Raul Barete

Role: primary

Other Identifiers

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IRB-47676

Identifier Type: -

Identifier Source: org_study_id

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