Testing a Brief Substance Misuse Preventative Intervention for Parents/Guardians of 5th-7th Grade Students

NCT ID: NCT03925220

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2025-01-30

Brief Summary

The current study aims to test the efficacy of a family communication-based, novel, adaptable, and resource-efficient substance misuse preventive intervention for parents/guardians of pre/early adolescents (grades 5-7). The short-term goal of this study is to increase the quality time that parents spend with their children through eating meals together, and in so doing, talking about the harms associated with substance use (intermediate endpoint), which will in turn, lead to the long-term goal of preventing the initiation and misuse of substances among their children as they enter adolescence.

Detailed Description

The prevention of substance use and misuse among adolescents is a national public health priority. Universal prevention programs that include parents/guardians (referred to as "parents") in this effort have been shown to prevent and reduce substance use problems among adolescents. However, the programs that have been most effective are resource and participant intensive. In addition, the majority of the current programs are not gender-specific and in some cases, long-term effects have been shown for one gender but not the other. The purpose of the current study is to test the efficacy of a brief, communication-based, substance use preventive intervention for parents of pre/early adolescents. The proposal is based on data from a study funded by the National Institute on Drug Abuse (NIDA) where the investigative team conducted a pilot randomized controlled trial (RCT) of the intervention among 70 parents/guardians and their children. The intervention was found to be acceptable and feasible to participants and families in the intervention had increased parent-child communication about substance use compared to those in the control condition. The purpose of the pilot study was to lay the groundwork for a large-scale trial of the intervention with 500 parent-child dyads. The brief intervention framework utilizes a one-time live (in person or remote) session and a follow-up phone call with a communication specialist to facilitate parents' roles as preventionists, which will focus on family interactions at meals, the role of peers in substance use, and parent-child communication about substance use. For this live session, parents will be asked to review a handbook with gender-specific information that emphasizes engaging in family meals, communication, and talking with their child about the harms of substance use. For the home-based component, tips and reminders with content from the handbooks will be sent via text messages throughout the three-month study period. Parents in the comparison condition will receive a handbook, similar in length and structure, on nutrition and physical activity, as well as receive comparison text messages and meet with a study team member. All study materials will be available in English and Spanish. It is hypothesized that over the study period, parents randomized to the intervention will have an increased frequency of parent-child communication about substance use. It is also hypothesized that these parents will have more positive and fewer negative family interactions during meals and qualitatively better content of conversations about substance use with their children compared to parents in the comparison condition. Furthermore, it is hypothesized that compared to children of parents in the comparison condition, children of parents who receive the intervention will self-report reduced intentions and willingness to use substances, reduced affiliation with substance-using peers, and increased negative attitudes and expectancies regarding substance use, and secondarily, lower rates of substance use initiation.

Conditions

Substance-Related Disorders; Underage Drinking; Drug Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Substance Use Prevention Intervention

Parents will be given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents will then participate in a one-hour session with an interventionist where the main points in the handbook will be reviewed and they will fill out an action plan on how to make changes in communication about substances with their child. The interventionist will also provide parents with a referral packet. Two weeks after the live session, participants will have a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents will receive two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants will receive a magnet about the importance of family meals that they will be instructed to put on their refrigerators.

Group Type: EXPERIMENTAL

The SUPPER Project

Intervention Type: BEHAVIORAL

Substance Use Promoted by Eating family meals Regularly

Nutrition, Physical Activity, and Weight Talk Comparison

For the comparison condition, after the baseline assessment, parents will receive a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents will also receive a magnet with a message about nutrition and exercise. To control for contact time, these participants will meet live with a study staff member two weeks after receiving the handbook, complete an action plan, and have the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.

Group Type: ACTIVE_COMPARATOR

Improving nutrition and physical activity among youth

Intervention Type: BEHAVIORAL

A brief intervention focused on improving nutrition and physical activity among youth

Interventions

The SUPPER Project

Substance Use Promoted by Eating family meals Regularly

Intervention Type: BEHAVIORAL

Improving nutrition and physical activity among youth

A brief intervention focused on improving nutrition and physical activity among youth

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The parent/guardian must have a child between 5th-7th grades at the start of the project;
• The parent must be the custodial parent, living with the child at least 50% of the time (as in the case of joint custody); and
• Parental consent and child assent are obtained.

Exclusion Criteria

• Parents of children with self-identified developmental disabilities who would have difficulty understanding the baseline assessment; and
• Parents or families who are not able to speak, read, and understand English or Spanish well enough to complete study procedures.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Margie Skeer

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margie Skeer, ScD, MPH, MSW

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Medicine

Locations

Tufts University School of Medicine

Boston, Massachusetts, United States

Countries

United States

References

Skeer MR, Sabelli RA, Rancano KM, Lee-Bravatti M, Ryan EC, Eliasziw M, Spirito A. Randomized controlled trial to test the efficacy of a brief, communication-based, substance use preventive intervention for parents of adolescents: Protocol for the SUPPER Project (Substance Use Prevention Promoted by Eating family meals Regularly). PLoS One. 2022 Feb 2;17(2):e0263016. doi: 10.1371/journal.pone.0263016. eCollection 2022.

Reference Type: DERIVED

PMID: 35108294 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DA045073-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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