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NCT04333966: PRISM

Parental Research on Interventions for Social Media

Completed NA Results posted Last updated 24 October 2024
What this trial tests

NA trial testing Interactive Social Networking Site Parent Based Intervention in Underage Drinking in 202 participants. Completed in 15 March 2024.

Timeline
1 February 2023
Primary endpoint
15 March 2024
15 March 2024

Quick facts

Lead sponsorUniversity of North Texas Health Science Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment202
Start date1 February 2023
Primary completion15 March 2024
Estimated completion15 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Texas Health Science Center

Who can join

15 and older, any sex, with Underage Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability (Parent)- Program Usefulness Primary · Data will be collected at 1 month follow-up

Percentage of parents in the interactive PBI condition who agreed or strongly agreed that the program was useful

GroupValue95% CI
Interactive PBI42
Acceptability (Parent)- Relationship Primary · Data will be collected at 1 month follow-up

Percentage of parents assigned to Interactive PBI who agreed or strongly agreed that the program helped their relationship with their teen

GroupValue95% CI
Interactive PBI45
Acceptability (Teen)- Relationship Primary · Data will be collected at 1 month follow-up

Percentage of teens assigned to interactive PBI who agreed or strongly agreed that the program helped their relationship with their parent

GroupValue95% CI
Interactive PBI41
Acceptability (Teen)- Percentage Who Would Recommend the Program Primary · Data will be collected at 1 month follow-up

Percentage of teens assigned to the interactive PBI who would recommend the program

GroupValue95% CI
Interactive PBI45
Acceptability (Parent)- Percentage Who Would Recommend the Program Primary · Data will be collected at 1 month follow-up

Percentage of parents assigned to interactive PBI who would recommend the program

GroupValue95% CI
Interactive PBI45
Drinking Days in Past Month (Teen) Secondary · Data will be collected at 1 month follow-up

Number of drinking days in the past month.

GroupValue95% CI
Interactive PBI0.24± 0.88
Active Control0.26± 0.86
Drinking Days in Past Month (Teen) Secondary · Data will be collected at 6 month follow-up

Number of drinking days in the past month.

GroupValue95% CI
Interactive PBI0.18± 0.51
Active Control0.76± 2.36
Communication About Alcohol and Social Media (Parent) Secondary · Data will be collected at 1 month follow-up

Extent to which parent spoke to teen about alcohol and social media in past month ranging from 1 = not at all to 4 = a great deal.

GroupValue95% CI
Interactive PBI2.03± 0.68
Active Control1.79± 0.64
Communication About Alcohol and Social Media (Parent) Secondary · Data will be collected at 6 month follow-up

Extent to which parent spoke to teen about alcohol and social media in past month from 1= not at all to 4= a great deal.

GroupValue95% CI
Interactive PBI1.80± 0.80
Active Control1.66± 0.66
Communication About Alcohol and Social Media (Teen) Secondary · Data will be collected at 1 month follow-up

Extent to which teen spoke to teen about alcohol and social media in past month from 1= not at all to 4 = a great deal.

GroupValue95% CI
Interactive PBI1.65± 0.68
Active Control1.53± 0.61
Communication About Alcohol and Social Media (Teen) Secondary · Data will be collected at 6 month follow-up

Extent to which teen spoke to teen about alcohol and social media in past month from 1= not at all to 4= a great deal.

GroupValue95% CI
Interactive PBI1.48± 0.53
Active Control1.33± 0.48

Sponsor's own description

The prevalence of underage alcohol use continues to be a public health concern. Numerous studies have reported associations between teen drinking tendencies and parental attitudes and beliefs, parental awareness of teen drinking, parental monitoring and the quality of the parent-teen relationship and communication. The extensive work in this area has resulted in parent-based intervention (PBI) efforts to prevent or reduce adolescent alcohol use. Several independent studies have indicated that teens whose parents received a PBI reported less alcohol use and fewer alcohol-related consequences. Despite these strengths, one major limitation of PBI is that they do not currently take into account the large role that social networking sites (SNS) use plays in adolescents' lives and in relation to their alcohol use. Most (90%) adolescents are on SNS, and their Facebook, Instagram, and Twitter profiles include alcohol content. Thus, adolescents are making and exposed to SNS alcohol displays and these displays are associated with high-risk drinking cognitions and alcohol use. As such, the investigators propose to develop and refine an interactive PBI designed to reduce high-risk SNS cognitions (i.e. attitudes and norms), alcohol use, and negative consequences among adolescents. To achieve study aims, the investigators propose an iterative process of focus groups in order to develop and refine the interactive PBI to be delivered in the pilot study with 1 and 6-month follow-up among 100 parent/teen dyads. The objective of this R34 application is to establish feasibility and acceptability of the newly developed interactive PBI that focuses on the role of SNS in adolescent alcohol use as well as to determine preliminary effect sizes for future studies. Determining an efficacious way to reduce alcohol use and high-risk alcohol display cognitions affords future research the opportunity to make use of social network-based interventions, thus the proposed research has great potential to serve as a catalyst for future research.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Parent-Based Intervention for Reducing High-risk Social Media Cognitions, Alcohol Use, and Negative Consequences Among Adolescents: Protocol for a Randomized Controlled Pilot Study.
    Litt DM, Geusens F, Seamster A, Lewis MA. · · 2022 · cited 2× · PMID 35579931 · DOI 10.2196/38543

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04333966.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing