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Underage DrinkingPRISMNCT04333966

Parental Research on Interventions for Social Media

A study testing Interactive Social Networking Site Parent Based Intervention in people with Underage Drinking, run by University of North Texas Health Science Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Underage Drinking
What is being tested?
Interactive Social Networking Site Parent Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteUnited States
Study dates
1 Feb 2023to 15 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • have a child between the ages of 15-20 who currently lives with them
  • believe that their child is active on at least one SNS
  • live in Texas
  • valid email address
  • own a cell phone with text messaging capabilities and be ok with receiving messages
  • provide valid contact information for their teen
Show all 13Show fewer
  • and willing to complete a 6 month long pilot study
  • being between the ages of 15-20
  • be active on at least one SNS
  • live in Texas
  • valid email address
  • own a cell phone with text messaging capabilities and be ok with receiving messages
  • and willing to complete a 6 month long pilot study

Who cannot join

  • not meeting inclusion criteria
  • unwillingness to participate
  • failure to provide consent (e.g., declining participation in the study)
  • providing inconsistent responses (e.g., age) identified by the survey and introductory study telephone call
  • and having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

Other trials in United States

About this study

Official title: Parental Research on Interventions for Social Media (Project PRISM)

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.

Read the detailed description

Although adolescents spend an increasing amount of time with their friends, parents remain an important source of support and continue to play a key role in the lives of their adolescents. The extensive work in this area has resulted in parent based intervention (PBI) efforts to prevent or reduce adolescent alcohol use. Research has shown that teens whose parents received a PBI reported less alcohol use and fewer alcohol related consequences up to 9-month follow-up relative to controls. However, one major limitation of PBIs is that they do not currently take into account the large role that social networking sites (SNS) play 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 cognitions and alcohol use. Research has argued that existing parental mediation techniques grounded primarily on television/film media have fundamental inadequacies when applied to more interactive media such as websites, social media, and mobile apps as they do not account for the interactivity, immersive virtual environments, and mediated communication innate to SNS. Further, most PBIs are presented in static manual form. The investigators are unaware of any study to date that has developed and tested an interactive PBI about alcohol use and the role of SNS in adolescent alcohol use. As such, the investigators propose to develop and refine an interactive PBI designed to reduce both high-risk SNS cognitions and alcohol use among adolescents. This application responds to PA-18-067 "Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials" as it aims 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. The specific aims are as follows: Aim 1: Develop and refine an interactive PBI targeting the influence of SNS on high-risk SNS cognitions and alcohol use among adolescents. Interactive PBI content and text message prompts will be developed through focus groups, which will inform a new interactive PBI to be tested in a pilot study (Aim 2). A total of 16 focus groups (8 parent, 8 teen) will be conducted with 8-10 people in each group with parents only being in focus groups with other parents and teens being only with other teens. Focus groups will occur in two phases whereby an initial sample of participants (4 parent and 4 teen focus groups) will engage in parent and teen specific focus groups (split by age of teen-15-17 and 18-20) in which they will be asked to view and interact with the interactive SNS PBI and generate additional PBI content. Based on focus group data from the first round of focus groups, revisions will be made for use in the remaining 8 focus groups (4 parent, 4 teen). Aim 2: Conduct a pilot study with parents and their adolescents aged 15-20 from the Dallas/Fort Worth (DFW) area to determine feasibility, acceptability, and preliminary effect sizes (to estimate power and sample size for a future R01 application). Parent/teen dyads (N=100) will be randomized to interactive PBI (n=50) or active control (n=50) with a 1- and 6-month follow-up. Parents in the interactive PBI condition will receive the interactive web-based SNS PBI with text message prompts developed and finalized through Aim 1 focus groups. Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families. General Hypotheses (parent and teen). The investigators hypothesize that the interactive SNS PBI will be feasible (i.e., number of eligible participants, number of parents who gave consent, number of teens who gave consent, length of time to achieve planned recruitment and enrollment goal, rate of study completion and rate of study attrition) and acceptable (i.e., proportion of parents and teens who find the intervention acceptable; ease of viewing and interacting with interactive PBI content; relevance of material; finding content helpful, beneficial, important; ratings of individual web-based modules and text messages of the PBI; the proportion of parents and teens who would recommend the study to other families, and the proportion of parents and teens who found the interactive PBI to be favorable overall) relative to active control. The investigators further hypothesize that teens and parents in the interactive PBI condition will report more positive communication about alcohol and SNS at the 1- and 6-month follow-up relative to active control. Parent Hypotheses: The investigators hypothesize that at 1- and 6-month follow-up, parents in the interactive PBI condition will report greater knowledge about alcohol as well as the role of SNS in alcohol use relative to active control. Teen Hypotheses: The investigators hypothesize that teens in the interactive PBI condition will report less drinking, fewer alcohol-related negative consequences, less favorable attitudes toward posting about alcohol on SNS, greater perceived vulnerability to the risks of posting alcohol displays on SNS, and decreased normative perceptions about how many teens post alcohol displays on SNS relative to active control at 1- and 6-month follow-up.

Being tested
Interactive Social Networking Site Parent Based Intervention, Active Control
Medical subject headings
Underage Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive Social Networking Site Parent Based InterventionBehavioural

    Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.

  • Active ControlBehavioural

    Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.

Study groups in NCT04333966
Study groupRoleWhat they receive
Interactive PBIExperimentalParents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
Receives: Behavioral: Interactive Social Networking Site Parent Based Intervention
Active ControlActive comparatorParents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families.
Receives: Behavioral: Active Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability (Parent)- Program Usefulness

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

    Measured: Data will be collected at 1 month follow-up

  2. Acceptability (Parent)- Relationship

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

    Measured: Data will be collected at 1 month follow-up

  3. Acceptability (Teen)- Relationship

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

    Measured: Data will be collected at 1 month follow-up

  4. Acceptability (Teen)- Percentage Who Would Recommend the Program

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

    Measured: Data will be collected at 1 month follow-up

  5. Acceptability (Parent)- Percentage Who Would Recommend the Program

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

    Measured: Data will be collected at 1 month follow-up

Secondary outcomes (6)
  1. Drinking Days in Past Month (Teen)

    Number of drinking days in the past month.

    Measured: Data will be collected at 1 month follow-up

  2. Drinking Days in Past Month (Teen)

    Number of drinking days in the past month.

    Measured: Data will be collected at 6 month follow-up

  3. Communication About Alcohol and Social Media (Parent)

    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.

    Measured: Data will be collected at 1 month follow-up

  4. Communication About Alcohol and Social Media (Parent)

    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.

    Measured: Data will be collected at 6 month follow-up

  5. Communication About Alcohol and Social Media (Teen)

    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.

    Measured: Data will be collected at 1 month follow-up

  6. Communication About Alcohol and Social Media (Teen)

    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.

    Measured: Data will be collected at 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start1 Feb 2023
  3. Primary completion15 Mar 2024
  4. Study completion15 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04333966
Sponsor's protocol ID
2019-035
Other IDs
1R34AA026332-01A1
Acronym
PRISM
Status last verified
Sep 2024
First submitted
30 Mar 2020
Last updated
24 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: A select number of researchers will have access to unidentified participant data at the close of the study.

Publications

  • Currie, C. N. G. S., Roberts, C., Morgan, A., Smith, R., Settertobulte, W., Samdal, O., & Barnekow, V. (2012). Health policy for children and adolescents. Copenhagen: WHO Regional Office for Europe, 252.

  • Steinberg, L. (2001). We know some things: Parent-adolescent relationships in retrospect and prospect. Journal of Research on Adolescence, 11(1), 1-19. doi: 10.1111/1532-7795.00001

  • Steinberg L. Clinical adolescent psychology: what it is, and what it needs to be. J Consult Clin Psychol. 2002 Feb;70(1):124-8. doi: 10.1037//0022-006x.70.1.124.

    PubMed 11860038
  • Turrisi R, Padilla KK, Wiersma KA. College student drinking: an examination of theoretical models of drinking tendencies in freshmen and upperclassmen. J Stud Alcohol. 2000 Jul;61(4):598-602. doi: 10.15288/jsa.2000.61.598.

    PubMed 10928730
  • Ichiyama MA, Fairlie AM, Wood MD, Turrisi R, Francis DP, Ray AE, Stanger LA. A randomized trial of a parent-based intervention on drinking behavior among incoming college freshmen. J Stud Alcohol Drugs Suppl. 2009 Jul;(16):67-76. doi: 10.15288/jsads.2009.s16.67.

    PubMed 19538914
  • Turrisi R, Jaccard J, Taki R, Dunnam H, Grimes J. Examination of the short-term efficacy of a parent intervention to reduce college student drinking tendencies. Psychol Addict Behav. 2001 Dec;15(4):366-72. doi: 10.1037//0893-164x.15.4.366.

    PubMed 11767270
  • Turrisi R, Abar C, Mallett KA, Jaccard J. An Examination of the Mediational Effects of Cognitive and Attitudinal Factors of a Parent Intervention to Reduce College Drinking. J Appl Soc Psychol. 2010 Oct 1;40(10):2500-2526. doi: 10.1111/j.1559-1816.2010.00668.x.

    PubMed 21318080
  • Lenhart, A. (2015). Teens, Social Media & Technology Overview 2015. Pew Research Center . Retrieved from http://www.pewinternet.org/2015/04/09/teens-social-media-technology-2015/

  • Cavazos-Rehg PA, Krauss MJ, Sowles SJ, Bierut LJ. "Hey Everyone, I'm Drunk." An Evaluation of Drinking-Related Twitter Chatter. J Stud Alcohol Drugs. 2015 Jul;76(4):635-43. doi: 10.15288/jsad.2015.76.635.

    PubMed 26098041
  • Moreno MA, Parks M, Richardson LP. What are adolescents showing the world about their health risk behaviors on MySpace? MedGenMed. 2007 Oct 11;9(4):9.

    PubMed 18311359
  • Moreno MA, Parks MR, Zimmerman FJ, Brito TE, Christakis DA. Display of health risk behaviors on MySpace by adolescents: prevalence and associations. Arch Pediatr Adolesc Med. 2009 Jan;163(1):27-34. doi: 10.1001/archpediatrics.2008.528.

    PubMed 19124700
  • Litt, D. Spiro, E., M., Swanson, A., & Lewis, M. A. (2018). Does Twitter referent matter?: The relationship between self versus other Twitter chatter and alcohol use and consequences among young adults. Manuscript submitted for publication.

  • Litt DM, Stock ML. Adolescent alcohol-related risk cognitions: the roles of social norms and social networking sites. Psychol Addict Behav. 2011 Dec;25(4):708-13. doi: 10.1037/a0024226. Epub 2011 Jun 6.

    PubMed 21644803
  • Moreno MA, Christakis DA, Egan KG, Brockman LN, Becker T. Associations between displayed alcohol references on Facebook and problem drinking among college students. Arch Pediatr Adolesc Med. 2012 Feb;166(2):157-63. doi: 10.1001/archpediatrics.2011.180. Epub 2011 Oct 3.

    PubMed 21969360
  • Jiow, H. J., Lim, S. S., & Lin, J. (2016). Level Up! Refreshing Parental Mediation Theory for Our Digital Media Landscape. Communication Theory, 27(3), 309-328. doi:10.1111/comt.12109

Questions about this trial

What is this clinical trial studying?

A study testing Interactive Social Networking Site Parent Based Intervention in people with Underage Drinking, run by University of North Texas Health Science Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability (Parent)- Program Usefulness (time frame: Data will be collected at 1 month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04333966, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.

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