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N/A N=804 Randomized Single-blind Prevention

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

Substance-Related Disorders · Underage Drinking · Drug Use

Enrolled (actual)
804
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Frequency of Parent-child Conversations on Substances — 87; 32; 29; 20 Participants — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
The SUPPER Project (Behavioral); Improving nutrition and physical activity among youth (Behavioral)
Age
Pediatric · 9+ yrs
Sex
All
Sponsor
Tufts University
Primary completion
Jan 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Frequency of Parent-child Conversations on Substances
87; 32; 29; 20; 91; 146 <0.001 sig
PRIMARY
Targeted Parent-child Communication on Substance Use
162; 147; 126; 143; 19; 34 <0.001 sig
PRIMARY
Parent-child Audio-recorded Conversations About Substance Use
3.5; 3.2; 4.7; 4.6; 5.5; 5.5
PRIMARY
Quality of Video-recorded Family Mealtime Interactions
28.9; 28.6; 30.3; 30.1; 25.7; 25.8
PRIMARY
Child Substance Use Expectancies (Alcohol)
2.55; 2.53; 4.24; 4.23
PRIMARY
Child Substance Use Expectancies (Cigarettes)
1.68; 1.57; 5.15; 5.22
PRIMARY
Child Substance Use Expectancies (Marijuana)
2.69; 2.73; 4.04; 4.16
PRIMARY
Child Affiliation With Substance-using Peers
21; 15; 124; 126; 11; 4
PRIMARY
Child Willingness to Use Substances
0.27; 0.26; 0.22; 0.13; 0.24; 0.15
PRIMARY
Child Intentions to Use Substances
0; 0; 147; 146; 0; 0
SECONDARY
Pre/Early-adolescent Substance Use Initiation
14; 9; 173; 173; 3; 2

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03925220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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