Clinical trial NCT05722535: Using Shared Decision Making to Improve Family Media Use Planning
Official title: Using Shared Decision Making to Improve Family Media Use Planning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Behavior
Keywords: Screen Media Use
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators will conduct a pilot randomized controlled trial assessing the efficacy and feasibility of the newly developed Family Media Check-In (FMC).

Detailed description: The clinical trial portion of this study will enroll 150 families (child age 11-17, and at least one parent/guardian). Stratified randomization will be used to assign families to the intervention (FMC) or control (delayed FMC) condition. Families assigned to the intervention condition will be asked to complete the FMC within 2 weeks of randomization and will be sent a second survey one week after 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 two months after their second survey.

The primary outcomes will be measured at the first follow-up period and will be related to screen media planning and decision making. Two-month follow-up surveys will explore intervention impact on screen media practices.

Prior to the clinical trial portion of the study, the study team conducted interviews/focus groups, participatory design sessions, and usability testing sessions with a diverse group of families to refine the concept for the intervention and to iteratively develop the intervention itself. Changes in the behavioral targets and components of the intervention and outcomes for the evaluation (relative to the original grant proposal) were driven by family-expressed needs and priorities.

Eligibility criteria: 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

Primary outcomes:
measure: Decision Satisfaction
timeFrame: Baseline, 3 weeks post-baseline
measure: Decision Uncertainty
timeFrame: Baseline, 3 weeks post-baseline
measure: Change in Family Media Planning and Plan Engagement
timeFrame: Baseline, 3 weeks post-baseline
measure: Teen Involvement in Plan
timeFrame: Baseline, 3 weeks post-baseline
Secondary outcomes:
measure: Screen Media Conflict
timeFrame: Baseline, 3 weeks post-baseline
measure: Screen-Related Parenting Style
timeFrame: Baseline, 3 weeks post-baseline
measure: Acceptability of FMC
timeFrame: 1 week post-intervention / 3 weeks post-baseline
Other outcomes:
measure: Amount of Use
timeFrame: Baseline, 3 weeks post-baseline
measure: Social Media Addiction
timeFrame: Baseline, 3 weeks post-baseline
measure: Change in Problematic Media use
timeFrame: Baseline, 3 weeks post-baseline
measure: Parent Distracted Media Use
timeFrame: Baseline, 3 weeks post-baseline
measure: Emotional Health
timeFrame: Baseline, 3 weeks post-baseline
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
References: