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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05332275
Other study ID # IRB202101350 -N-R
Secondary ID R34DA052793PRO00
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date May 31, 2025

Study information

Verified date June 2024
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Entertainment media commonly depict SU, and youth exposure to media SU is linked to youth initiation and progression of SU behavior. Parenting practices reduce exposure to and may mitigate risk associated with media depictions of SU, thus this research proposal will build upon current understanding of effective media parenting with the end goal of developing and testing a media parenting intervention designed to reduce youth risk for SU.


Description:

Youth substance use (SU) is associated with many negative developmental outcomes including morbidity and mortality. Initiation of SU typically occurs during adolescence, and SU behavior often co-occurs with other risk behaviors (e.g., risky sexual behavior). Exposure to SU in the media is a well-documented influence on SU behavior, as it predicts early onset SU and progression to more problematic SU behavior. Media effects, while demonstrated to be consistent, stable, and strong even accounting for other social influences and personality characteristics, have received little attention in preventative SU research; yet youth exposure to media SU is a modifiable environmental risk for youth SU behavior. Parents can mitigate SU risk by limiting media SU exposures and intervening when youth are exposed. Parents report lack of media parenting skills, however, and no media parenting intervention designed specifically to reduce youth risk for SU exists. This project will examine the role of media parenting behaviors to reduce risk for early onset of youth SU. This program of research focuses on media depictions of SU, an important social and environmental influence implicated in the development, maintenance, and treatment of SU disorders. Specifically, the aims of this project are to target media-related mechanisms underlying SU initiation and associated risk factors as they relate to youth development. Improved understanding of specific parenting behaviors that contribute to prevention of youth SU, and mechanisms by which parenting behaviors may reduce risk related to media could inform the development of new and more effective interventions. Research aims in this application are designed to progress towards the end goal of developing a scalable, evidence-informed media parenting intervention to reduce youth risk for SU. First, intervention content that follows the T.E.C.H. Parenting framework developed by Gabrielli and Marsch will be refined with two focus groups of approximately 8 parents each (Aim 1). Once intervention content is finalized, using randomized control trial (RCT) design with an attention control comparison group, the T.E.C.H. Parenting intervention will be tested in a sample of 120 parent participants (Aim 2). Innovations include the use of web-based intervention content with supplemental push messaging to participants. Implementation data will be collected as part of the RCT to determine feasibility of web-delivered components of intervention content as well as usability and acceptability of intervention content from participants. This project is highly innovative in the use of technology to support parental engagement and dissemination of intervention. Further, web delivery of content provides an opportunity for parents to practice media parenting skills within the digital environment in a way that is adapted to the needs of the individual family and can be implemented in a range of diverse clinical settings.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 14 Years
Eligibility Inclusion Criteria: Parents must - have at least one middle school-aged child who resides with them - be able to read at the 6th grade level in English - have access to the internet and a smartphone to participate in web-based intervention groups and receive intervention push messages. Exclusion Criteria: -NA

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention Arm - T.E.C.H. Parenting
Intervention Arm participants will enroll in a web-based psychoeducational group (15 parents per group across 4 groups). Participants will receive psychoeducational information on media parenting, and they will be invited to participate in an online group discussion board to share their experiences with other parents in the intervention. In weeks 2-5, participants will learn about 4 domains of media parenting: 1) Talk to your child about media; 2) Educate your child about media-related risks; 3) Co-View/Co-Use media and technology actively with your child; and 4) establish House rules for media usage. Week 6 will review information and provide an "expert clinician" to support parent problem solving. Participants will receive 2-3 weekly push messages via text messaging prompting practice of skills learned in the group setting. Participants will be assessed at baseline, immediately following the 6 week intervention, and 3 months after the intervention is completed.
Control Arm - General Positive Parenting
The Control Arm of the RCT is the attention control group. These participants will enroll in a web-based psychoeducational group (four groups of 15 parents each). They will receive 6 weeks of online psychoeducational material, including 2-3 push messages prompting skill practice. Parents will have access to an online discussion board to share experiences with other parents. This group will match the intervention arm of the study in number of study staff contacts, time of start/duration of the group, peer support, and availability of a professional in week six for consultation on parenting issues. Control participants will not receive information on media parenting. Participants in this group will be assessed at baseline, immediately following the six-week intervention period, and 3 months after intervention completion. Participants will be asked about exposure to TECH Parenting content at baseline and followup to address potential contamination effects across study arms.

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Media Parenting Behavior - Parent Report The TECH Parenting measure is a 24 item indicator of general media parenting behaviors across four 6-item subscales: Talk; Educate; Co-Use; and House Rules. This measure has demonstrated reliability and predictive value for youth online risk behaviors. Baseline up to Year 3
See also
  Status Clinical Trial Phase
Completed NCT03048552 - Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3 N/A