An interventional study of Media Ready Parent and Active Control Program in Substance Use, Parenting and Communication, sponsored by Innovation Research & Training. Completed at 1 site in United States. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Innovation Research & Training · Not applicable, Interventional, and Prevention
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.
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.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's enrollment of 576 is above the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
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Exclusion Criteria:
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.
Behavioral: Media Ready Parent
The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
Behavioral: Active Control Program
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.
The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
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
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
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
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
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
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
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
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
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
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
| Milestone | Web-based Intervention | Active Control Program |
|---|---|---|
| Started | 304 | 272 |
| Completed pretest | 206 | 188 |
| Completed | 175 | 174 |
| Not completed | 129 | 98 |
| Withdrew: Lost to follow-up | 129 | 98 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4 | 3.12 ± 0.03 | 3.11 ± 0.03 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Child Report of Parent-child Communication Quality at Week 4 | 2.97 ± 0.04 | 2.95 ± 0.04 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4 | 4.00 ± 0.08 | 3.87 ± 0.09 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4 | 3.66 ± 0.09 | 3.60 ± 0.09 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4 | 3.74 ± 0.09 | 3.42 ± 0.09 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Child Report of Parental Active Media Mediation at Week 4 | 3.27 ± 0.10 | 3.46 ± 0.10 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4 | 3.38 ± 0.08 | 3.36 ± 0.08 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4 | 3.15 ± 0.09 | 3.23 ± 0.09 |
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").
| percentage of participants with "1" | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Child Substance Use Intentions at Week 4 | 22.54 | 29.49 |
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.
| score on a scale | Web-based Intervention | Active Control Program |
|---|---|---|
| Change From Baseline in Child Willingness to Use Substances at Week 4 | 1.26 ± .04 | 1.26 ± .04 |
Collected over Adverse event data was collected from pretest to posttest completion: approximately 4 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Web-based Intervention | 0/304 (0%) | 0/304 (0%) | 0/304 (0%) |
| Active Control Program | 0/272 (0%) | 0/272 (0%) | 0/272 (0%) |
Intervention group included 206 participants (103 parents and 103 children). The control group included 188 participants (94 parents and 94 children).
| Age, Continuous(years) | Web-based Intervention | Active Control Program | Total |
|---|---|---|---|
| Parent | 43.19 ± 7.26 | 40.85 ± 6.76 | 42.08 ± 7.11 |
| Child | 12.64 ± 1.14 | 12.66 ± 1.36 | 12.65 ± 1.24 |
| Sex/Gender, Customized(Participants) | Web-based Intervention | Active Control Program | Total |
|---|---|---|---|
| Parent — Woman/Girl | 52 | 52 | 104 |
| Parent — Man/Boy | 50 | 41 | 91 |
| Parent — Nonbinary | 1 | 1 | 2 |
| Parent — Missing | 0 | 0 | 0 |
| Child — Woman/Girl | 46 | 43 | 89 |
| Child — Man/Boy | 56 | 48 | 104 |
| Child — Nonbinary | 0 | 2 | 2 |
| Child — Missing | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Web-based Intervention | Active Control Program | Total |
|---|---|---|---|
| Parent — Hispanic or Latino | 13 | 10 | 23 |
| Parent — Not Hispanic or Latino | 82 | 78 | 160 |
| Parent — Unknown or Not Reported | 8 | 6 | 14 |
| Child — Hispanic or Latino | 25 | 19 | 44 |
| Child — Not Hispanic or Latino | 78 | 74 | 152 |
| Child — Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Web-based Intervention | Active Control Program | Total |
|---|---|---|---|
| Parent — American Indian or Alaska Native | 0 | 0 | 0 |
| Parent — Asian | 2 | 2 | 4 |
| Parent — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Parent — Black or African American | 20 | 14 | 34 |
| Parent — White | 69 | 65 | 134 |
| Parent — More than one race | 3 | 5 | 8 |
| Parent — Unknown or Not Reported | 9 | 8 | 17 |
| Child — American Indian or Alaska Native | 1 | 0 | 1 |
| Child — Asian | 3 | 2 | 5 |
| Child — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Child — Black or African American | 15 | 14 | 29 |
| Child — White | 70 | 62 | 132 |
| Child — More than one race | 11 | 14 | 25 |
| Child — Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(Participants) | Web-based Intervention | Active Control Program | Total |
|---|---|---|---|
| United States | 206 | 188 | 394 |
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