Parental Research on Interventions for Social Media (PRISM)
Primary Purpose
Underage Drinking
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive Social Networking Site Parent Based Intervention
Active Control
Sponsored by
About this trial
This is an interventional prevention trial for Underage Drinking
Eligibility Criteria
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.
Sites / Locations
- University of North Texas Health Science CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interactive PBI
Active Control
Arm Description
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 active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families.
Outcomes
Primary Outcome Measures
Daily Drinking Questionnaire
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.
Daily Drinking Questionnaire
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.
Daily Drinking Questionnaire
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.
Parental Communication
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).
Parental Communication
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).
Parental Communication
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).
Study Feasibility- Enrollment
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.
Study Feasibility- Completion
Feasibility will be assessed by (1) the proportion of parent and teens who complete the interactive SNS PBI at 1 month follow-up.
Study Acceptability
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04333966
First Posted
March 30, 2020
Last Updated
May 23, 2023
Sponsor
University of North Texas Health Science Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04333966
Brief Title
Parental Research on Interventions for Social Media
Acronym
PRISM
Official Title
Parental Research on Interventions for Social Media (Project PRISM)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Texas Health Science Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underage Drinking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interactive PBI
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families.
Intervention Type
Behavioral
Intervention Name(s)
Interactive Social Networking Site Parent Based Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
Primary Outcome Measure Information:
Title
Daily Drinking Questionnaire
Description
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.
Time Frame
Data will be collected at baseline
Title
Daily Drinking Questionnaire
Description
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.
Time Frame
Data will be collected at 1 month follow-up
Title
Daily Drinking Questionnaire
Description
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.
Time Frame
Data will be collected at 6 month follow-up
Title
Parental Communication
Description
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).
Time Frame
Data will be collected at baseline
Title
Parental Communication
Description
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).
Time Frame
Data will be collected at 1 month follow-up
Title
Parental Communication
Description
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).
Time Frame
Data will be collected at 6 month follow-up
Title
Study Feasibility- Enrollment
Description
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.
Time Frame
Data will be collected at baseline
Title
Study Feasibility- Completion
Description
Feasibility will be assessed by (1) the proportion of parent and teens who complete the interactive SNS PBI at 1 month follow-up.
Time Frame
Data will be collected at 1 month follow-up
Title
Study Acceptability
Description
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
Time Frame
Data will be collected at 1 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana M Litt, PhD
Phone
817-735-5453
Ext
5453
Email
Dana.Litt@unthsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raul Resendiz
Phone
817-735-2371
Ext
2371
Email
raul.resendizgonzalez@unthsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana M Litt, PhD
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana M Litt, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
A select number of researchers will have access to unidentified participant data at the close of the study.
Citations:
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