Using Shared Decision Making to Improve Family Media Use Planning

Adolescent Behavior Clinical Trial

Official title:

Using Shared Decision Making to Improve Family Media Use Planning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722535
• Other study ID #: 5R21HD107230
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2022
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Seattle Children's Hospital
• Contact: Emily Kroshus, ScD MPH
• Phone: 206-884-5326
• Email: emily.kroshus[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators will conduct a pilot randomized controlled trial assessing the efficacy and feasibility of the newly developed Media Discussion and Planning Tool (MDPT).

Description:

The clinical trial portion of this study will enroll 150 families (child age 11-17, and at least one parent/guardian) with demographic quotas to construct a sampling frame that is nationally representative in terms of race/ethnicity, parent education and income. Stratified randomization will be used to assign families to the intervention (MDPT) or control (delayed MDPT) condition. Families assigned to the intervention condition will be asked to complete the MDPT within 2 weeks of randomization and will be sent a second survey one week after plan completion. Participants in the control condition will complete a condition-specific subset of these questions three weeks after baseline. Participants in both conditions will complete a follow-up survey assessing media use and health behaviors two months after their second survey.

The primary outcomes will be change in adolescent and parent media use practices, and key mediators will be core components of shared decision making process (i.e., informed, clear on values, engaged in planning and decision making), implementation readiness (i.e., self-efficacy) and within-family communication. Two-month follow-up surveys will provide preliminary data about maintenance of behavioral changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

Inclusion Criteria:

• Children between the ages of 11 and 17

• Parent/guardian of a child between the ages of 11 and 17

• English speaking

Exclusion Criteria:

• Parent/guardian or child does not want to participate (i.e., dyads only)

• Non-English speaking

Related Conditions & MeSH terms

• Adolescent Behavior

Intervention

Behavioral:
• Media Discussion and Planning Tool (MDPT)
An interactive, web-based tool to support within-family media use planning will be developed and shared with families.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adolescent Media Rule Engagement	Media Rule Engagement Scale, an 11 item 5 point Likert scale with a higher score indicating a higher level of engagement in media rules	Baseline, 3 weeks post-baseline, 3 months post-baseline
Primary	Change in Problematic Media use	Problematic Media Use Measure- Short Form, a 9 item scale which measures elements of addictive media use among children, including preoccupation, withdrawal, and unsuccessful attempts to control use by parents. Responses are recorded on a 5 point Likert scale with higher scores indicating more problematic media use.	Baseline, 3 weeks post-baseline, 3 months post-baseline
Secondary	Implementation Readiness	Self-report scales about parent and adolescent implementation readiness (implementation self efficacy, family resources and support, social influences on implementation, behavioral regulation)	1 week post-intervention
Secondary	Decision and goal setting	Self-report scales of how parent and adolescent feel about making media use decisions (feeling informed about risks, clarity on what matters most, perceived benefits and barriers of shared decision making)	Baseline, 1 week post-intervention
Secondary	Within family communication	Self-report scales about within-family communication (autonomy supportive parenting, parent-adolescent communication)	Baseline, 3 weeks post-baseline, 3 months post-baseline
Secondary	Feasibility and acceptability of MDPT	Feasibility of Intervention Measure, a 4 item 4 point Likert scale with higher score indicating a higher level of feasibility; Acceptability of Intervention Measure, a 4 item 4 point Likert scale with higher score indicating a higher level of acceptability	1 week post-intervention