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The Reducing Risk Study

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT03665337
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mTranS-C
  • Behavioral: Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
Primary Purpose:
Prevention
Official Title:
Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: mTranS-C

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

Behavioral: mTranS-C
MOBILE HEALTH
Active Comparator: Control

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

Behavioral: Control
MOBILE HEALTH

Outcome Measures

Primary Outcome Measures

  1. Change in Pittsburgh Sleep Quality Index (PSQI) [baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8]

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

Secondary Outcome Measures

  1. Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression) [baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8]

    A validated questionnaire measuring depressive symptom severity. The total score ranges between 0 and 19. Scores are rated as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-19).

  2. Change in the SCARED (Screen for Child Anxiety Related Disorders) total score [baseline, and at months 1, 2, 3 and 8]

    A validated 41-item questionnaire assessing self-report of anxiety in children and adolescents. Individual items are rated 'Not True or Hardly Ever True' (Score 0), 'Somewhat True or Sometimes True' (Score 1), or 'Very True or Often True' (Score 2). Individual response scores are then summed and for a total score. Total scores range from 0 to 82.

  3. Change in cortisol reactivity and recovery in response to a stress exposure [baseline and at month 3]

    A validated biological measure of stress reactivity and recovery in response to a stress exposure. Changes in cortisol production at 15, 30 and 45 minutes following a stressor will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

  • Principal Investigator: Lauren Asarnow, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT03665337
Other Study ID Numbers:
  • IRB-47676
First Posted:
Sep 11, 2018
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Aug 15, 2022