Using Shared Decision Making to Improve Family Media Use Planning

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05722535
Collaborator
(none)
300
1
2
9
33.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Media Discussion and Planning Tool (MDPT)
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Using Shared Decision Making to Improve Family Media Use Planning
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Delayed MDPT

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

Experimental: MDPT

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

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Adolescent Media Rule Engagement [Baseline, 3 weeks post-baseline, 3 months post-baseline]

    Media Rule Engagement Scale, an 11 item 5 point Likert scale with a higher score indicating a higher level of engagement in media rules

  2. Change in Problematic Media use [Baseline, 3 weeks post-baseline, 3 months post-baseline]

    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.

Secondary Outcome Measures

  1. Implementation Readiness [1 week post-intervention]

    Self-report scales about parent and adolescent implementation readiness (implementation self efficacy, family resources and support, social influences on implementation, behavioral regulation)

  2. Decision and goal setting [Baseline, 1 week post-intervention]

    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)

  3. Within family communication [Baseline, 3 weeks post-baseline, 3 months post-baseline]

    Self-report scales about within-family communication (autonomy supportive parenting, parent-adolescent communication)

  4. Feasibility and acceptability of MDPT [1 week post-intervention]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seattle Children's Hospital Seattle Washington United States 98105

Sponsors and Collaborators

  • Seattle Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Kroshus, Research Associate Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT05722535
Other Study ID Numbers:
  • 5R21HD107230
First Posted:
Feb 10, 2023
Last Update Posted:
Feb 10, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 10, 2023