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

• ClinicalTrials.gov Identifier: NCT03780088
• Recruitment Status: Completed
• First Posted: December 19, 2018
• Last Update Posted: August 17, 2021
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

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
Insomnia; Delayed Sleep Phase	Behavioral: mTranS-C	Not Applicable

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 (Clinical Trial)
• 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: January 16, 2019
• Actual Primary Completion Date: February 1, 2021
• Actual Study Completion Date: April 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) [ 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 Outcome Measures :

1. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: 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) [ Time Frame: 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

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

Criteria

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

United States, California

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

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03780088
• Other Study ID Numbers: 46142
• First Posted: December 19, 2018
• Last Update Posted: August 17, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• 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; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders