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Parental Research on Interventions for Social Media

Parental Research on Interventions for Social Media (Project PRISM)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04333966
Acronym
PRISM
Enrollment
202
Registered
2020-04-03
Start date
2023-02-01
Completion date
2024-03-15
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Underage Drinking

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.

Interventions

BEHAVIORALInteractive Social Networking Site Parent Based Intervention

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.

BEHAVIORALActive Control

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

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of North Texas Health Science Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability (Parent)- Percentage Who Would Recommend the ProgramData will be collected at 1 month follow-upPercentage of parents assigned to interactive PBI who would recommend the program
Acceptability (Parent)- RelationshipData will be collected at 1 month follow-upPercentage of parents assigned to Interactive PBI who agreed or strongly agreed that the program helped their relationship with their teen
Acceptability (Teen)- RelationshipData will be collected at 1 month follow-upPercentage of teens assigned to interactive PBI who agreed or strongly agreed that the program helped their relationship with their parent
Acceptability (Teen)- Percentage Who Would Recommend the ProgramData will be collected at 1 month follow-upPercentage of teens assigned to the interactive PBI who would recommend the program
Acceptability (Parent)- Program UsefulnessData will be collected at 1 month follow-upPercentage of parents in the interactive PBI condition who agreed or strongly agreed that the program was useful

Secondary

MeasureTime frameDescription
Communication About Alcohol and Social Media (Parent)Data will be collected at 1 month follow-upExtent 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.
Communication About Alcohol and Social Media (Teen)Data will be collected at 1 month follow-upExtent to which teen spoke to teen about alcohol and social media in past month from 1= not at all to 4 = a great deal.
Drinking Days in Past Month (Teen)Data will be collected at 1 month follow-upNumber of drinking days in the past month.

Countries

United States

Participant flow

Pre-assignment details

Only parent and teen dyads and who had both completed baseline were considered enrolled. The numbers in each milestone represent the total number of participants (parents and teens combined).

Participants by arm

ArmCount
Interactive PBI (Parents and Teens Combined)
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. Interactive Social Networking Site Parent Based Intervention: 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 and teens completed both baseline, 1 month, and 6-month follow-up. Baseline measure sample sizes are presented for parents and teens combined for each arm.
100
Control Condition (Parents and Teens Combined)
Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families. Parents and teens completed both baseline, 1 month, and 6-month follow-up. Baseline measure sample sizes are presented for parents and teens combined for each arm.
102
Total202

Baseline characteristics

CharacteristicInteractive PBI (Parents and Teens Combined)Control Condition (Parents and Teens Combined)Total
Age, Categorical
Parents
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Parents
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Parents
Between 18 and 65 years
50 Participants51 Participants101 Participants
Age, Categorical
Teens
<=18 years
40 Participants46 Participants86 Participants
Age, Categorical
Teens
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Teens
Between 18 and 65 years
10 Participants5 Participants15 Participants
Drinking Days per Month0.15 days
STANDARD_DEVIATION 0.65
0.22 days
STANDARD_DEVIATION 0.62
0.18 days
STANDARD_DEVIATION 0.63
Ethnicity (NIH/OMB)
Parents
Hispanic or Latino
13 Participants33 Participants46 Participants
Ethnicity (NIH/OMB)
Parents
Not Hispanic or Latino
37 Participants18 Participants55 Participants
Ethnicity (NIH/OMB)
Parents
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Teens
Hispanic or Latino
16 Participants33 Participants49 Participants
Ethnicity (NIH/OMB)
Teens
Not Hispanic or Latino
32 Participants15 Participants47 Participants
Ethnicity (NIH/OMB)
Teens
Unknown or Not Reported
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Parents
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Parents
Asian
6 Participants2 Participants8 Participants
Race (NIH/OMB)
Parents
Black or African American
13 Participants12 Participants25 Participants
Race (NIH/OMB)
Parents
More than one race
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Parents
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parents
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Parents
White
29 Participants31 Participants60 Participants
Race (NIH/OMB)
Teens
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Teens
Asian
9 Participants4 Participants13 Participants
Race (NIH/OMB)
Teens
Black or African American
7 Participants12 Participants19 Participants
Race (NIH/OMB)
Teens
More than one race
4 Participants5 Participants9 Participants
Race (NIH/OMB)
Teens
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Teens
Unknown or Not Reported
4 Participants1 Participants5 Participants
Race (NIH/OMB)
Teens
White
26 Participants28 Participants54 Participants
Region of Enrollment
United States
100 participants102 participants0 participants
Sex: Female, Male
Parents
Female
41 Participants43 Participants84 Participants
Sex: Female, Male
Parents
Male
9 Participants8 Participants17 Participants
Sex: Female, Male
Teens
Female
26 Participants28 Participants54 Participants
Sex: Female, Male
Teens
Male
24 Participants23 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1000 / 102
other
Total, other adverse events
0 / 1000 / 102
serious
Total, serious adverse events
0 / 1000 / 102

Outcome results

Primary

Acceptability (Parent)- Percentage Who Would Recommend the Program

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

Time frame: Data will be collected at 1 month follow-up

Population: Only participants assigned to interactive PBI received this item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Interactive PBIAcceptability (Parent)- Percentage Who Would Recommend the Program45 Participants
Primary

Acceptability (Parent)- Program Usefulness

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

Time frame: Data will be collected at 1 month follow-up

Population: Only parents in the interactive PBI condition received this item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Interactive PBIAcceptability (Parent)- Program Usefulness42 Participants
Primary

Acceptability (Parent)- Relationship

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

Time frame: Data will be collected at 1 month follow-up

Population: Only parents assigned to interactive PBI received this item

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Interactive PBIAcceptability (Parent)- Relationship45 Participants
Primary

Acceptability (Teen)- Percentage Who Would Recommend the Program

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

Time frame: Data will be collected at 1 month follow-up

Population: Only participants assigned to interactive PBI received this item.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Interactive PBIAcceptability (Teen)- Percentage Who Would Recommend the Program45 Participants
Primary

Acceptability (Teen)- Relationship

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

Time frame: Data will be collected at 1 month follow-up

Population: Only participants assigned to interactive PBI received this item

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Interactive PBIAcceptability (Teen)- Relationship41 Participants
Secondary

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.

Time frame: Data will be collected at 1 month follow-up

Population: All parents who completed the 1-month followup survey.

ArmMeasureValue (MEAN)Dispersion
Interactive PBICommunication About Alcohol and Social Media (Parent)2.03 units on a scaleStandard Deviation 0.68
Active ControlCommunication About Alcohol and Social Media (Parent)1.79 units on a scaleStandard Deviation 0.64
Secondary

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.

Time frame: Data will be collected at 6 month follow-up

Population: All parents who completed 6-month followup

ArmMeasureValue (MEAN)Dispersion
Interactive PBICommunication About Alcohol and Social Media (Parent)1.80 units on a scaleStandard Deviation 0.8
Active ControlCommunication About Alcohol and Social Media (Parent)1.66 units on a scaleStandard Deviation 0.66
Secondary

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.

Time frame: Data will be collected at 6 month follow-up

Population: All teens who completed 6-month follow-up.

ArmMeasureValue (MEAN)Dispersion
Interactive PBICommunication About Alcohol and Social Media (Teen)1.48 units on a scaleStandard Deviation 0.53
Active ControlCommunication About Alcohol and Social Media (Teen)1.33 units on a scaleStandard Deviation 0.48
Secondary

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.

Time frame: Data will be collected at 1 month follow-up

Population: All teens who completed 1-month follow-up

ArmMeasureValue (MEAN)Dispersion
Interactive PBICommunication About Alcohol and Social Media (Teen)1.65 units on a scaleStandard Deviation 0.68
Active ControlCommunication About Alcohol and Social Media (Teen)1.53 units on a scaleStandard Deviation 0.61
Secondary

Drinking Days in Past Month (Teen)

Number of drinking days in the past month.

Time frame: Data will be collected at 1 month follow-up

Population: Only those participants who completed the 1-month follow-up were analyzed.

ArmMeasureValue (MEAN)Dispersion
Interactive PBIDrinking Days in Past Month (Teen)0.24 Number of daysStandard Deviation 0.88
Active ControlDrinking Days in Past Month (Teen)0.26 Number of daysStandard Deviation 0.86
Secondary

Drinking Days in Past Month (Teen)

Number of drinking days in the past month.

Time frame: Data will be collected at 6 month follow-up

Population: Only participants who completed 6 month follow-up were analyzed

ArmMeasureValue (MEAN)Dispersion
Interactive PBIDrinking Days in Past Month (Teen)0.18 number of daysStandard Deviation 0.51
Active ControlDrinking Days in Past Month (Teen)0.76 number of daysStandard Deviation 2.36

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026