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

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Delayed Sleep Phase
• Intervention / Treatment: Behavioral: mTranS-C

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Atherton, California, United States, 94027
      • Gardner Packard Children's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire 9 (PHQ-9)	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).	baseline to end of treatment (anticipated average exposure 2 months), and month 5
Strengths & Difficulties Questionnaire (SDQ)	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.	baseline and at months 2 and 5

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): April 15, 2021

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 46142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No