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Clinical Trials/NCT05722535
NCT05722535
Recruiting
N/A

Using Shared Decision Making to Improve Family Media Use Planning

Seattle Children's Hospital2 sites in 1 country300 target enrollmentJuly 10, 2022

Overview

Phase
N/A
Intervention
Delayed FMC
Conditions
Adolescent Behavior
Sponsor
Seattle Children's Hospital
Enrollment
300
Locations
2
Primary Endpoint
Decision Satisfaction
Status
Recruiting
Last Updated
4 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2022
End Date
August 1, 2026
Last Updated
4 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Kroshus

Research Associate Professor

Seattle Children's Hospital

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

Arms & Interventions

Delayed FMC

Families assigned to the control condition will receive the FMC after study completion.

FMC

Families randomized to the intervention condition will receive the FMC after they complete the baseline survey.

Intervention: Family Media Check-In (FMC)

Outcomes

Primary Outcomes

Decision Satisfaction

Time Frame: Baseline, 3 weeks post-baseline

Perceived Effective Decision Scale: a 4-item measure that assesses parent and teen satisfaction with their family media plan. Responses are measured on a 5-point Likert scale, with higher scores indicating a stronger perception of decision effectiveness.

Decision Uncertainty

Time Frame: Baseline, 3 weeks post-baseline

Decision Uncertainty Scale: a 3-item scale adapted for the intervention and nature of decision designed to measure parent and teen perceptions of uncertainty when making decisions. The items evaluate factors contributing to uncertainty, including difficulty, lack of clarity, and indecision. Responses are recorded on a 5-point Likert scale. Higher scores indicate greater levels of perceived uncertainty, with the third item reverse-scored.

Change in Family Media Planning and Plan Engagement

Time Frame: Baseline, 3 weeks post-baseline

Family Media Planning and Engagement Scale. This scale includes two components, each with 3 items: elements included in plan and engagement with plan. Higher scores indicate more screen media-related elements included in plan and greater teen engagement with plan.

Teen Involvement in Plan

Time Frame: Baseline, 3 weeks post-baseline

This single-item assesses the degree of involvement teens perceive they had in creating the plan. Response options range from full individual control to full parent parental control, with options capturing varying levels of shared-decision making

Secondary Outcomes

  • Screen Media Conflict(Baseline, 3 weeks post-baseline)
  • Screen-Related Parenting Style(Baseline, 3 weeks post-baseline)
  • Acceptability of FMC(1 week post-intervention / 3 weeks post-baseline)

Study Sites (2)

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