Communication, Parenting, Substance Use
Conditions
Brief summary
The goal of this study is to test the feasibility of a web-based program for parents of middle school aged students. 286 parents and their child in 6th, 7th, or 8th grade will be asked to each complete two online questionnaires over the course of about a month, parents will also complete a web-based program between questionnaires. Researchers will compare the intervention and an active control to test the intervention program efficacy for improving outcomes related to parent-child communication, media message processing, and adolescent health.
Detailed description
The purpose of this study is to evaluate and assess a self-administered, web-based program designed to increase parent knowledge about adolescent substance use, active media mediation skills, and practice high-quality parent-adolescent communication methods. The program will help parents of middle-school aged students, 6th-8th graders, communicate effectively about substance use and enhance media literacy skills to counter unhealthy media messages. Prevention efforts are most impacting for adolescents in middle school years as this is the time frame for growing independence, desire to fit-in and an increase risk for their own experimentation with substances.
Interventions
BEHAVIORALMedia Ready Parent
The intervention is a web-based resource that provides parents with media literacy and media mediation skills, knowledge about adolescent development and substance use, and practice in high quality parent-child communication.
BEHAVIORALActive Control Program
The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
Sponsors
National Institute on Drug Abuse (NIDA)
Innovation Research & Training
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will not be informed which condition they are assigned (intervention or active control). All measures are assessed using a web-based data collection system rather than a human outcomes assessor.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The adult must be the legal guardian of a child in 6th, 7th or 8th grade (known hereafter as parent). * The parent must be able and willing to receive email and text communication as part of the study. * The parent-child pair must have access to a smartphone with internet connection as the resource review will be completed online in a format that is best viewed on a smartphone. * The parent-child pair must be fluent in English as the study materials are conducted in English. * The parent must indicate that they will give the child participant privacy to complete the questionnaires * Both the adult and child must agree to participate.
Exclusion criteria
* In an effort to ensure diversity in parent gender and race/ethnicity, not all eligible pairs who are interested in participating will be enrolled in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4 | Baseline and Week 4 | Parent-child communication quality will be adapted from the 16-item Parent-Adolescent Communication Scale (PACS; Barnes & Olson, 1985; Prado et al., 2007; α = .85). Participants are asked to indicate on a 4-point scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the extent to which they agree with a series of 16 statements (e.g., I can discuss my beliefs with my child without feeling embarrassed). Higher scores indicate a better outcome. Responses on the items were averaged together. |
| Change From Baseline in Child Report of Parent-child Communication Quality at Week 4 | Baseline and Week 4 | Parent-child communication quality will be adapted from the 16-item Parent-Adolescent Communication Scale (PACS; Barnes & Olson, 1985; Prado et al., 2007; α = .85). Participants are asked to indicate on a 4-point scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the extent to which they agree with a series of 16 statements (e.g., I can discuss my beliefs with my parent without feeling embarrassed). Higher scores indicate a better outcome. Responses were averaged together. |
| Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4 | Baseline and Week 4 | Parent-child communication behaviors about substance use will be assessed by asking a series of 5 questions to assess the frequency of parent-child communication about alcohol, tobacco, vaping, marijuana, and prescription drugs (e.g., How much have you talked with your child about alcohol use?; 5-point Likert-type scale ranging from 1=Never to 5=Extremely Much). Adapted from adapted from Miller-Day & Kam (2010). Higher values indicate a better outcome. Responses were averaged together. |
| Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4 | Baseline and Week 4 | Parent-child communication behaviors about substance use will be assessed by asking a series of 5 questions to assess the frequency of parent-child communication about alcohol, tobacco, vaping, marijuana, and prescription drugs (e.g., How much has your parent talked with you about alcohol use?; 5-point Likert-type scale ranging from 1=Never to 5=Extremely Much). Adapted from adapted from Miller-Day & Kam (2010). Higher values indicate a better outcome. Responses were averaged together. |
| Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4 | Baseline and Week 4 | Parents' use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do you tell your child that what they see in media (like movies/TV, commercials, social media, and online content like YouTube) is different than real life?) measured on a 5-point Likert-type scale (1=Never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together. |
| Change From Baseline in Child Report of Parental Active Media Mediation at Week 4 | Baseline and Week 4 | Child report of parent's use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). Child report of parent use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do your parents tell you that what they see in media (like movies/TV, commercials, social media, and online content like YouTube) is different than real life?) measured on a 5-point Likert-type scale (1=Never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together. |
| Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4 | Baseline and Week 4 | Parents' use of restrictive media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013).The scale consists of four items (e.g., How often do you limit the amount of your child's screen time (watching shows, going online, playing video games, or using social media?) measured on a 5-point Likert-type scale (1=never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together. |
| Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4 | Baseline and Week 4 | Child report of parent's use of restrictive media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do your parents tell you that you are not allowed to watch certain TV shows or movies because they are meant for adults?) measured on a 5-point Likert-type scale (1=never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together. |
| Change From Baseline in Child Substance Use Intentions at Week 4 | Baseline and Week 4 | Substance use intentions will be assessed by asking During the next year, do you think you will drink alcohol (4-point scale; 1=I definitely will not; 2=I probably will not; 3=I probably will; 4=I definitely will; higher scores indicate a worse outcome). Questions will also be asked for use of tobacco, vape, marijuana, and prescription drugs without a prescription, for a total of 5 questions. Responses were averaged together and then dichotomized. Any participant with a mean of one (I definitely will not) was rescored as 0 (no intentions) and any participant with a mean greater than one was rescored as 1 (any intentions). A rescored value of 1 indicated a worse outcome. Outcome measure type (number) indicates the percentage of people who had a rescored value of 1 (any intentions). |
| Change From Baseline in Child Willingness to Use Substances at Week 4 | Baseline and Week 4 | Willingness to use substances will be assessed by asking Suppose you were with a group of kids and they were drinking alcohol. How willing would you be to have a drink? (4-point scale; 1=very unwilling; 2=unwilling; 3=willing; 4=very willing). Questions will also be asked for smoking, vaping, marijuana, and taking prescription drugs without a prescription. A total of 5 question will be asked, one for each substance type. Higher scores indicate a worse outcome. Responses were averaged. |
Countries
United States
Participant flow
Pre-assignment details
The number of participants in the Participant Flow data table represent the number of individual participants.
Participants by arm
| Arm | Count |
|---|---|
| Web-based Intervention The intervention is a web-based resource that provides parents with media literacy and media mediation skills, knowledge about adolescent development and substance use, and practice in high quality parent-child communication.
Media Ready Parent: The intervention is a web-based resource that provides parents with media literacy and media mediation skills, knowledge about adolescent development and substance use, and practice in high quality parent-child communication. | 206 |
| Active Control Program The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
Active Control Program: The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use. | 188 |
| Total | 394 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 129 | 98 |
Baseline characteristics
| Characteristic | Web-based Intervention | Active Control Program | Total |
|---|---|---|---|
| Age, Continuous Child | 12.64 years STANDARD_DEVIATION 1.14 | 12.66 years STANDARD_DEVIATION 1.36 | 12.65 years STANDARD_DEVIATION 1.24 |
| Age, Continuous Parent | 43.19 years STANDARD_DEVIATION 7.26 | 40.85 years STANDARD_DEVIATION 6.76 | 42.08 years STANDARD_DEVIATION 7.11 |
| Ethnicity (NIH/OMB) Child Hispanic or Latino | 25 Participants | 19 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Child Not Hispanic or Latino | 78 Participants | 74 Participants | 152 Participants |
| Ethnicity (NIH/OMB) Child Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Parent Hispanic or Latino | 13 Participants | 10 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Parent Not Hispanic or Latino | 82 Participants | 78 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Parent Unknown or Not Reported | 8 Participants | 6 Participants | 14 Participants |
| Race (NIH/OMB) Child American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Child Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Child Black or African American | 15 Participants | 14 Participants | 29 Participants |
| Race (NIH/OMB) Child More than one race | 11 Participants | 14 Participants | 25 Participants |
| Race (NIH/OMB) Child Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Child White | 70 Participants | 62 Participants | 132 Participants |
| Race (NIH/OMB) Parent American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Parent Black or African American | 20 Participants | 14 Participants | 34 Participants |
| Race (NIH/OMB) Parent More than one race | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Parent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Unknown or Not Reported | 9 Participants | 8 Participants | 17 Participants |
| Race (NIH/OMB) Parent White | 69 Participants | 65 Participants | 134 Participants |
| Region of Enrollment United States | 206 Participants | 188 Participants | 394 Participants |
| Sex/Gender, Customized Child Man/Boy | 56 Participants | 48 Participants | 104 Participants |
| Sex/Gender, Customized Child Missing | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Child Nonbinary | 0 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Child Woman/Girl | 46 Participants | 43 Participants | 89 Participants |
| Sex/Gender, Customized Parent Man/Boy | 50 Participants | 41 Participants | 91 Participants |
| Sex/Gender, Customized Parent Missing | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Parent Nonbinary | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Parent Woman/Girl | 52 Participants | 52 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 304 | 0 / 272 |
| other Total, other adverse events | 0 / 304 | 0 / 272 |
| serious Total, serious adverse events | 0 / 304 | 0 / 272 |
Outcome results
Primary
Change From Baseline in Child Report of Parental Active Media Mediation at Week 4
Child report of parent's use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). Child report of parent use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do your parents tell you that what they see in media (like movies/TV, commercials, social media, and online content like YouTube) is different than real life?) measured on a 5-point Likert-type scale (1=Never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together.
Time frame: Baseline and Week 4
Population: If a participant was missing any data on any covariates, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Child Report of Parental Active Media Mediation at Week 4 | 3.27 score on a scale | Standard Error 0.1 |
| Active Control Program | Change From Baseline in Child Report of Parental Active Media Mediation at Week 4 | 3.46 score on a scale | Standard Error 0.1 |
p-value: 0.18Regression, Linear
Primary
Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4
Child report of parent's use of restrictive media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do your parents tell you that you are not allowed to watch certain TV shows or movies because they are meant for adults?) measured on a 5-point Likert-type scale (1=never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together.
Time frame: Baseline and Week 4
Population: If a participant was missing any data on any covariates, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4 | 3.15 score on a scale | Standard Error 0.09 |
| Active Control Program | Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4 | 3.23 score on a scale | Standard Error 0.09 |
p-value: 0.56Regression, Linear
Primary
Change From Baseline in Child Report of Parent-child Communication Quality at Week 4
Parent-child communication quality will be adapted from the 16-item Parent-Adolescent Communication Scale (PACS; Barnes & Olson, 1985; Prado et al., 2007; α = .85). Participants are asked to indicate on a 4-point scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the extent to which they agree with a series of 16 statements (e.g., I can discuss my beliefs with my parent without feeling embarrassed). Higher scores indicate a better outcome. Responses were averaged together.
Time frame: Baseline and Week 4
Population: If a participant was missing data for any independent or dependent variables, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Child Report of Parent-child Communication Quality at Week 4 | 2.97 score on a scale | Standard Error 0.04 |
| Active Control Program | Change From Baseline in Child Report of Parent-child Communication Quality at Week 4 | 2.95 score on a scale | Standard Error 0.04 |
p-value: 0.78Regression, Linear
Primary
Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4
Parent-child communication behaviors about substance use will be assessed by asking a series of 5 questions to assess the frequency of parent-child communication about alcohol, tobacco, vaping, marijuana, and prescription drugs (e.g., How much has your parent talked with you about alcohol use?; 5-point Likert-type scale ranging from 1=Never to 5=Extremely Much). Adapted from adapted from Miller-Day & Kam (2010). Higher values indicate a better outcome. Responses were averaged together.
Time frame: Baseline and Week 4
Population: If a participant was missing data for any independent or dependent variables, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4 | 3.66 score on a scale | Standard Error 0.09 |
| Active Control Program | Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4 | 3.60 score on a scale | Standard Error 0.09 |
p-value: 0.68Regression, Linear
Primary
Change From Baseline in Child Substance Use Intentions at Week 4
Substance use intentions will be assessed by asking During the next year, do you think you will drink alcohol (4-point scale; 1=I definitely will not; 2=I probably will not; 3=I probably will; 4=I definitely will; higher scores indicate a worse outcome). Questions will also be asked for use of tobacco, vape, marijuana, and prescription drugs without a prescription, for a total of 5 questions. Responses were averaged together and then dichotomized. Any participant with a mean of one (I definitely will not) was rescored as 0 (no intentions) and any participant with a mean greater than one was rescored as 1 (any intentions). A rescored value of 1 indicated a worse outcome. Outcome measure type (number) indicates the percentage of people who had a rescored value of 1 (any intentions).
Time frame: Baseline and Week 4
Population: Analyses were conducted using observed data instead of imputed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Web-based Intervention | Change From Baseline in Child Substance Use Intentions at Week 4 | 22.54 percentage of participants with 1 |
| Active Control Program | Change From Baseline in Child Substance Use Intentions at Week 4 | 29.49 percentage of participants with 1 |
p-value: 0.8595% CI: [0.38, 3.2]Regression, Logistic
Primary
Change From Baseline in Child Willingness to Use Substances at Week 4
Willingness to use substances will be assessed by asking Suppose you were with a group of kids and they were drinking alcohol. How willing would you be to have a drink? (4-point scale; 1=very unwilling; 2=unwilling; 3=willing; 4=very willing). Questions will also be asked for smoking, vaping, marijuana, and taking prescription drugs without a prescription. A total of 5 question will be asked, one for each substance type. Higher scores indicate a worse outcome. Responses were averaged.
Time frame: Baseline and Week 4
Population: If a participant was missing any data on any covariates, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Child Willingness to Use Substances at Week 4 | 1.26 score on a scale | Standard Error 0.04 |
| Active Control Program | Change From Baseline in Child Willingness to Use Substances at Week 4 | 1.26 score on a scale | Standard Error 0.04 |
p-value: 1Regression, Linear
Primary
Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4
Parents' use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do you tell your child that what they see in media (like movies/TV, commercials, social media, and online content like YouTube) is different than real life?) measured on a 5-point Likert-type scale (1=Never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together.
Time frame: Baseline and Week 4
Population: If a participant was missing any data on any covariates, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4 | 3.74 score on a scale | Standard Error 0.09 |
| Active Control Program | Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4 | 3.42 score on a scale | Standard Error 0.09 |
p-value: 0.01Regression, Linear
Primary
Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4
Parents' use of restrictive media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013).The scale consists of four items (e.g., How often do you limit the amount of your child's screen time (watching shows, going online, playing video games, or using social media?) measured on a 5-point Likert-type scale (1=never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together.
Time frame: Baseline and Week 4
Population: If a participant was missing any data on any covariates, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4 | 3.38 score on a scale | Standard Error 0.08 |
| Active Control Program | Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4 | 3.36 score on a scale | Standard Error 0.08 |
p-value: 0.83Regression, Linear
Primary
Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4
Parent-child communication quality will be adapted from the 16-item Parent-Adolescent Communication Scale (PACS; Barnes & Olson, 1985; Prado et al., 2007; α = .85). Participants are asked to indicate on a 4-point scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the extent to which they agree with a series of 16 statements (e.g., I can discuss my beliefs with my child without feeling embarrassed). Higher scores indicate a better outcome. Responses on the items were averaged together.
Time frame: Baseline and Week 4
Population: If a participant was missing data for any independent or dependent variables, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4 | 3.12 score on a scale | Standard Error 0.03 |
| Active Control Program | Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4 | 3.11 score on a scale | Standard Error 0.03 |
p-value: 0.77Regression, Linear
Primary
Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4
Parent-child communication behaviors about substance use will be assessed by asking a series of 5 questions to assess the frequency of parent-child communication about alcohol, tobacco, vaping, marijuana, and prescription drugs (e.g., How much have you talked with your child about alcohol use?; 5-point Likert-type scale ranging from 1=Never to 5=Extremely Much). Adapted from adapted from Miller-Day & Kam (2010). Higher values indicate a better outcome. Responses were averaged together.
Time frame: Baseline and Week 4
Population: If a participant was missing any data on any covariates, they were not included in the outcome analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Web-based Intervention | Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4 | 4.00 score on a scale | Standard Error 0.08 |
| Active Control Program | Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4 | 3.87 score on a scale | Standard Error 0.09 |
p-value: 0.28Regression, Linear