- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333966
Parental Research on Interventions for Social Media (PRISM)
December 6, 2023 updated by: University of North Texas Health Science Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dana M Litt, PhD
- Phone Number: 5453 817-735-5453
- Email: Dana.Litt@unthsc.edu
Study Contact Backup
- Name: Raul Resendiz
- Phone Number: 2371 817-735-2371
- Email: raul.resendizgonzalez@unthsc.edu
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76107
- Recruiting
- University of North Texas Health Science Center
-
Contact:
- Dana M Litt, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria (Parents):
- 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
- and willing to complete a 6 month long pilot study
Inclusion Criteria (Teens):
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interactive PBI
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.
|
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 Comparator: Active Control
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families.
|
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Drinking Questionnaire
Time Frame: Data will be collected at baseline
|
The DDQ (Collins, Parks, & Marlatt, 1985) measures the quantity and frequency of alcohol use by asking students to estimate the typical number of drinks consumed on each day of the week, averaged over the previous 3 months.
|
Data will be collected at baseline
|
Daily Drinking Questionnaire
Time Frame: Data will be collected at 1 month follow-up
|
The DDQ (Collins, Parks, & Marlatt, 1985) measures the quantity and frequency of alcohol use by asking students to estimate the typical number of drinks consumed on each day of the week, averaged over the previous 3 months.
|
Data will be collected at 1 month follow-up
|
Daily Drinking Questionnaire
Time Frame: Data will be collected at 6 month follow-up
|
The DDQ (Collins, Parks, & Marlatt, 1985) measures the quantity and frequency of alcohol use by asking students to estimate the typical number of drinks consumed on each day of the week, averaged over the previous 3 months.
|
Data will be collected at 6 month follow-up
|
Parental Communication
Time Frame: Data will be collected at baseline
|
Alcohol-related communication between parents and teens will be assessed with a measure adapted from (Turrisi et al., 2000) (# = .96).
Participants will also complete a measure of SNS and alcohol-related communication adapted from Turrisi et al., 2001; # = .96).
|
Data will be collected at baseline
|
Parental Communication
Time Frame: Data will be collected at 1 month follow-up
|
Alcohol-related communication between parents and teens will be assessed with a measure adapted from (Turrisi et al., 2000) (# = .96).
Participants will also complete a measure of SNS and alcohol-related communication adapted from Turrisi et al., 2001; # = .96).
|
Data will be collected at 1 month follow-up
|
Parental Communication
Time Frame: Data will be collected at 6 month follow-up
|
Alcohol-related communication between parents and teens will be assessed with a measure adapted from (Turrisi et al., 2000) (# = .96).
Participants will also complete a measure of SNS and alcohol-related communication adapted from Turrisi et al., 2001; # = .96).
|
Data will be collected at 6 month follow-up
|
Study Feasibility- Enrollment
Time Frame: Data will be collected at baseline
|
Feasibility will be assessed by (1) the proportion of parents who meet inclusion criteria and enroll for the study, and (2) the length of time it took to recruit our target enrollment number.
|
Data will be collected at baseline
|
Study Feasibility- Completion
Time Frame: Data will be collected at 1 month follow-up
|
Feasibility will be assessed by (1) the proportion of parent and teens who complete the interactive SNS PBI at 1 month follow-up.
|
Data will be collected at 1 month follow-up
|
Study Acceptability
Time Frame: Data will be collected at 1 month follow-up
|
Acceptability will be assessed with parent and teen responses at 1 month.
Acceptability will be determined by (1) the proportion of eligible parent/teen dyads enrolled, with 80% of eligible dyads agreeing to participate, (2) the proportion of participants (both parents and teens) who find the intervention acceptable (e.g., acceptability of content delivery method), usable (e.g., ease of viewing and interacting with interactive PBI content), relevant (e.g., relevance of material), and helpful (e.g., finding content helpful, beneficial, important), (3) parents' and teens' ratings of individual modules in the SNS PBI, (4) whether teens would like to have additional conversations on this topic, (5) whether parents would share the information in the PBI with anyone else, (6) the proportion of parents and teens who would recommend
|
Data will be collected at 1 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dana M Litt, PhD, University of North Texas Health Science Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Kuntsche S, Kuntsche E. Parent-based interventions for preventing or reducing adolescent substance use - A systematic literature review. Clin Psychol Rev. 2016 Apr;45:89-101. doi: 10.1016/j.cpr.2016.02.004. Epub 2016 Mar 23.
- Turrisi R, Mallett KA, Cleveland MJ, Varvil-Weld L, Abar C, Scaglione N, Hultgren B. Evaluation of timing and dosage of a parent-based intervention to minimize college students' alcohol consumption. J Stud Alcohol Drugs. 2013 Jan;74(1):30-40. doi: 10.15288/jsad.2013.74.30.
- Fournier A. K., Hall E., Ricke P., Storey B. (2013). Alcohol and the social network: online social networking sites and college students' perceived drinking norms. Psychol. Popular Media Cult. 2, 86-95. 10.1037/a0032097
- Jaccard, J. and Levitz, N. (2013). Parent-based interventions to reduce adolescent problem behaviors: New directions for self-regulation approaches In G. Oettingen and P. Gollwitzer (Eds.) Self-regulation in adolescence. New York: Cambridge University Press.
- Testa M, Hoffman JH, Livingston JA, Turrisi R. Preventing college women's sexual victimization through parent based intervention: a randomized controlled trial. Prev Sci. 2010 Sep;11(3):308-18. doi: 10.1007/s11121-010-0168-3.
- Litt DM, Geusens F, Seamster A, Lewis MA. 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. JMIR Res Protoc. 2022 May 17;11(5):e38543. doi: 10.2196/38543.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
March 30, 2020
First Submitted That Met QC Criteria
April 1, 2020
First Posted (Actual)
April 3, 2020
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-035
- 1R34AA026332-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
A select number of researchers will have access to unidentified participant data at the close of the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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