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Completed

NCT Number: NCT03780088

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

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.

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Key information

Conditions

Insomnia Delayed Sleep Phase Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gardner Packard Children's Health Center

Atherton, California, 94027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mTranS-C

Behavioral

mobile health

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2018
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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