跳至主要内容
临床试验/NCT05722535
NCT05722535招募中不适用

Using Shared Decision Making to Improve Family Media Use Planning

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Decision Satisfaction

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Delayed FMC

No Intervention

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

FMC

Experimental

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

干预措施: Family Media Check-In (FMC) (Behavioral)

结局指标

主要结局

Decision Satisfaction

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Kroshus

Research Associate Professor

Seattle Children's Hospital

研究点 (2)

Loading locations...

相似试验