Improving Access to Care: Testing an Integrated Care Mobile Health Intervention

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT03780088
Collaborator
(none)
52
1
1
26.9
1.9

Study Details

Study Description

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.

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

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
Actual Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Access to Care: Testing an Integrated Care Mobile Health Intervention to Improve Sleep and Mental Health in Adolescents
Actual Study Start Date :
Jan 16, 2019
Actual Primary Completion Date :
Feb 1, 2021
Actual Study Completion Date :
Apr 15, 2021

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

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh Sleep Quality Index (PSQI) [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 Outcome Measures

  1. Patient Health Questionnaire 9 (PHQ-9) [baseline to end of treatment (anticipated average exposure 2 months), and month 5]

    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. Strengths & Difficulties Questionnaire (SDQ) [baseline and at months 2 and 5]

    The Strengths and Difficulties Questionnaire (SDQ) is a validated 25 item behavioral screening questionnaire. Individual items are rated 'Somewhat True' (always scored as 1), 'Not True'(score is typically 0 except when reverse scored) and 'Certainly True' (score is typically 2 except when reverse scored). The SDQ comprise 5 scales (Prosocial, Peer Problems, Hyperactivity, Conduct and Emotional Problems) of 5 items each. For each of the 5 scales the score can range from 0 to 10 if all items were completed. These scores can be scaled up pro-rata if at least 3 items were completed, e.g. a score of 4 based on 3 completed items can be scaled up to a score of 7 (6.67 rounded up) for 5 items. A total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, and is counted as missing of one of the 4 component scores is missing.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gardner Packard Children's Health Center Atherton California United States 94027

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:
NCT03780088
Other Study ID Numbers:
  • 46142
First Posted:
Dec 19, 2018
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
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:

Study Results

No Results Posted as of Aug 17, 2021