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Clinical Trials/NCT03780088
NCT03780088CompletedNot Applicable

Improving Access to Care: Testing an Integrated Care Mobile Health Intervention to Improve Sleep and Mental Health in Adolescents

University of California, San Francisco1 site in 1 country52 target enrollmentStarted: January 16, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
1
Primary Endpoint
Pittsburgh Sleep Quality Index (PSQI)

Study Overview

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.

Detailed Description

This adaptation is designed to address the following key challenges to accessing care: (1) to overcome the challenge of low availability of qualified providers as a barrier to treatment access, we have adapted TranS-C for online and mobile device delivery (referred to as mTranS-C), thereby leveraging the high rates of mobile phone and internet use in adolescents; (2) to further increase access we will disseminate mTranS-C within primary care services, a proven strategy for improving access to behavioral health care; and (3) we focus on low-income communities, where there is a higher prevalence of sleep problems and low access to services.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

mTranS-C

Experimental

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

Intervention: mTranS-C (Behavioral)

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index (PSQI)

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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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