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NCT05900115

Feasibility Study of a Web-based Program to Help Parents of Middle School Students Effectively Communicate With Their Children About Substance Use

Completed NA Results posted Last updated 23 October 2024
What this trial tests

NA trial testing Media Ready Parent in Substance Use in 576 participants. Completed in 29 November 2023.

Timeline
8 May 2023
Primary endpoint
29 November 2023
29 November 2023

Quick facts

Lead sponsorInnovation Research & Training
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment576
Start date8 May 2023
Primary completion29 November 2023
Estimated completion29 November 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Innovation Research & Training

Who can join

10 and older, any sex, with Substance Use or Parenting. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4 Primary · 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.

GroupValue95% CI
Web-based Intervention3.12± 0.03
Active Control Program3.11± 0.03
Change From Baseline in Child Report of Parent-child Communication Quality at Week 4 Primary · 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.

GroupValue95% CI
Web-based Intervention2.97± 0.04
Active Control Program2.95± 0.04
Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4 Primary · 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.

GroupValue95% CI
Web-based Intervention4.00± 0.08
Active Control Program3.87± 0.09
Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4 Primary · 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.

GroupValue95% CI
Web-based Intervention3.66± 0.09
Active Control Program3.60± 0.09
Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4 Primary · 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.

GroupValue95% CI
Web-based Intervention3.74± 0.09
Active Control Program3.42± 0.09
Change From Baseline in Child Report of Parental Active Media Mediation at Week 4 Primary · 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 Like

GroupValue95% CI
Web-based Intervention3.27± 0.10
Active Control Program3.46± 0.10
Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4 Primary · 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.

GroupValue95% CI
Web-based Intervention3.38± 0.08
Active Control Program3.36± 0.08
Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4 Primary · 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.

GroupValue95% CI
Web-based Intervention3.15± 0.09
Active Control Program3.23± 0.09
Change From Baseline in Child Substance Use Intentions at Week 4 Primary · 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

GroupValue95% CI
Web-based Intervention22.54
Active Control Program29.49
Change From Baseline in Child Willingness to Use Substances at Week 4 Primary · 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.

GroupValue95% CI
Web-based Intervention1.26± .04
Active Control Program1.26± .04

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05900115.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing