I-ACT With Check Yourself

NCT ID: NCT02764190

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-11-30

Brief Summary

Adolescents have some of the highest rates of risk behaviors of all age groups and health behaviors developed in adolescence can persist into adulthood. These behaviors carry significant risks for subsequent disease, disability, and healthcare burden. Despite these risks, health risk screening in primary care is infrequently performed and results are rarely followed by targeted intervention. In response to the need for screening-linked interventions, our study team has developed a web-based, electronic Personalized Motivational Feedback tool which we refer to as "Check Yourself." Based on motivational interviewing, a technique to mobilize personal change, Check Yourself is designed to promote healthy choices for the multiple behaviors relevant to adolescents as well as to provide information to providers to promote discussions around health behaviors between providers and adolescents.

Building on electronic health interventions, primary care providers can play an essential role in helping adolescents to make healthy behavior choices. Emerging evidence suggests that the consistency of preventive counseling can be increased through provider training and the provision of screening tools; yet, we know very little about the quality of such counseling, and if it impacts outcomes that are important to adolescent patients themselves.

This study is a stepped-wedge, controlled trial comparing the effectiveness of an interactive adolescent-centered training for primary care providers (I-ACT) and Check Yourself to usual care. This study will take place in six pediatric practices. The purpose of this study is to determine whether this system of interventions (i.e., I-ACT, Check Yourself, and the summary report) is more effective than usual care in reducing health risk behaviors, improving adolescent motivation for health, and improving quality of care among adolescents receiving primary health care services.

Conditions

Adolescent Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

I-ACT with Check Yourself

Adolescents complete Check Yourself which delivers personalized, motivational feedback on their health behaviors prior to their primary care appointment. Check Yourself includes the provision of age normative feedback, goal setting strategies, and strategies to highlight discrepancies. Primary care providers will receive I-ACT and the Check Yourself summary report of health risk behaviors before an adolescent patient's appointment. I-ACT will provide training in adolescent-preferred communication methods and use of Check Yourself as a framework for the provider to use motivational interviewing to consider the patients' change readiness and their personal health goals. I-ACT includes online interactive, case-based learning, with booster sessions and feedback reports to reinforce new skills.

Group Type: EXPERIMENTAL

I-ACT with Check Yourself

Intervention Type: BEHAVIORAL

Usual care

In the usual care group, adolescents are asked to complete health risk screening on a computer. No personalized feedback is provided to adolescents and primary care providers do not receive I-ACT or the Check Yourself summary report of the adolescent's health risk behaviors.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

I-ACT with Check Yourself

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Eligible adolescent participants will be 13-18 years of age and caregiver participants will be 18 years of age or older and able to understand English. Eligible participants will have an appointment (or have a child with an appointment) with a participating medical practice.

Exclusion Criteria

• Adolescents will be excluded from the study if they do not meet age requirements, do not have an appointment with a participating provider at a PSPRN clinic, lack the means to complete follow-up interviews (i.e., have neither telephone nor internet access), have a sibling who has been/is being enrolled in the study or have previously participated in our previous trial comparing Check Yourself to usual care, and/or are not able to understand English.
• Caregivers will be excluded from the study if they do not speak English; or if their child is not eligible or declines to participate in the study .

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carolyn McCarty

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

McCarty CA, Parker E, Zhou C, Katzman K, Stout J, Richardson LP. Electronic Screening, Feedback, and Clinician Training in Adolescent Primary Care: A Stepped-Wedge Cluster Randomized Trial. J Adolesc Health. 2022 Feb;70(2):234-240. doi: 10.1016/j.jadohealth.2021.07.019. Epub 2021 Aug 14.

Reference Type: DERIVED

PMID: 34404610 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IHS-1402-10592

Identifier Type: -

Identifier Source: org_study_id