Clinical trial NCT03925220: Testing a Brief Substance Misuse Preventative Intervention for Parents/Guardians of 5th-7th Grade Students
Official title: Testing a Brief Substance Misuse Preventative Intervention for Parents of Youth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance-Related Disorders
Underage Drinking
Drug Use
Keywords: Primary Prevention
Adolescent Behavior
Family
Personal Communication
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2019-04-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Changes in frequency of parent-child conversations about substance use
timeFrame: Short-term (3 and 6 months); long-term (12 and 18 months)
measure: Changes in quality of parent-child conversations about substance use
timeFrame: Short-term (6 months); long-term (12 months)
measure: Changes in parent-child conversations about substance use
timeFrame: Short-term (3 and 6 months); long-term (12 and 18 months)
measure: Changes in quality of family mealtime interactions
timeFrame: Short-term (6 months); long-term (12 months)
measure: Changes in child substance use expectancies (alcohol)
timeFrame: 18 months
measure: Changes in child substance use expectancies (cigarettes)
timeFrame: 18 months
measure: Changes in child substance use expectancies (marijuana)
timeFrame: 18 months
measure: Changes in child affiliation with substance-using peers
timeFrame: 18 months
measure: Changes in child willingness to use substances
timeFrame: 18 months
measure: Changes in child intentions to use substances
timeFrame: 18 months
Secondary outcomes:
measure: Changes in pre/early-adolescent substance use initiation
timeFrame: 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Medicine
name: Margie Skeer, ScD, MPH, MSW
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.