NCT05900115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 23, 2024

Completed
Last Updated

October 23, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

June 2, 2023

Results QC Date

July 3, 2024

Last Update Submit

October 1, 2024

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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").

    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.

    Baseline and Week 4

Study Arms (2)

Web-based intervention

EXPERIMENTAL

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

Active Control Program

ACTIVE COMPARATOR

The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.

Behavioral: Active Control Program

Interventions

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.

Web-based intervention

The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.

Active Control Program

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

innovation Research and Training

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersCommunication

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Results Point of Contact

Title
Tracy Scull, PhD
Organization
innovation Research & Training

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

May 8, 2023

Primary Completion

November 29, 2023

Study Completion

November 29, 2023

Last Updated

October 23, 2024

Results First Posted

October 23, 2024

Record last verified: 2024-09

Locations