Last reviewed · How we verify

NCT03925220

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

Completed NA Results posted Last updated 9 July 2025
What this trial tests

NA trial testing The SUPPER Project in Substance-Related Disorders in 402 participants. Completed in 30 January 2025.

Timeline
6 March 2019
Primary endpoint
30 January 2025
30 January 2025

Quick facts

Lead sponsorTufts University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment402
Start date6 March 2019
Primary completion30 January 2025
Estimated completion30 January 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Tufts University

Who can join

Adults 9 to 14, any sex, with Substance-Related Disorders or Underage Drinking. 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.

Frequency of Parent-child Conversations on Substances Primary · 3 months (short-term) and 18 months (long-term)

Frequency of conversations was measured using an item adapted from a measure for parent-child communication about sex (Miller et al, 1998). Question: "During the past 3-months, how many times have you and your child talked about \[substance\]?" The same question assessed frequency for each substance of interest (alcohol, cigarettes, e-cigarettes, cannabis, other drugs) on a five-point Likert scale from "None" to "A lot". Responses were dichotomized as "Several" or "A lot" versus "None", "Once", or "A few times". This measure was reported by parents and children.

3-months - drinking alcohol
GroupValue95% CI
Substance Use Prevention Intervention87
Substance Use Prevention Intervention - Children32
Nutrition, Physical Activity, and Weight Talk Comparison29
Nutrition, Physical Activity, and Weight Talk Comparison - Children20
Substance Use Prevention Intervention91
Substance Use Prevention Intervention - Children146
Nutrition, Physical Activity, and Weight Talk Comparison156
Nutrition, Physical Activity, and Weight Talk Comparison - Children165
3-months - using e-cigarettes or vaping
GroupValue95% CI
Substance Use Prevention Intervention70
Substance Use Prevention Intervention - Children28
Nutrition, Physical Activity, and Weight Talk Comparison28
Nutrition, Physical Activity, and Weight Talk Comparison - Children17
Substance Use Prevention Intervention108
Substance Use Prevention Intervention - Children150
Nutrition, Physical Activity, and Weight Talk Comparison157
Nutrition, Physical Activity, and Weight Talk Comparison - Children168
3-months - using marijuana
GroupValue95% CI
Substance Use Prevention Intervention61
Substance Use Prevention Intervention - Children20
Nutrition, Physical Activity, and Weight Talk Comparison27
Nutrition, Physical Activity, and Weight Talk Comparison - Children17
Substance Use Prevention Intervention117
Substance Use Prevention Intervention - Children158
Nutrition, Physical Activity, and Weight Talk Comparison158
Nutrition, Physical Activity, and Weight Talk Comparison - Children168
3-months - smoking cigarettes
GroupValue95% CI
Substance Use Prevention Intervention79
Substance Use Prevention Intervention - Children28
Nutrition, Physical Activity, and Weight Talk Comparison23
Nutrition, Physical Activity, and Weight Talk Comparison - Children21
Substance Use Prevention Intervention99
Substance Use Prevention Intervention - Children150
Nutrition, Physical Activity, and Weight Talk Comparison162
Nutrition, Physical Activity, and Weight Talk Comparison - Children164
3-months - using other drugs
GroupValue95% CI
Substance Use Prevention Intervention55
Substance Use Prevention Intervention - Children25
Nutrition, Physical Activity, and Weight Talk Comparison20
Nutrition, Physical Activity, and Weight Talk Comparison - Children19
Substance Use Prevention Intervention123
Substance Use Prevention Intervention - Children153
Nutrition, Physical Activity, and Weight Talk Comparison165
Nutrition, Physical Activity, and Weight Talk Comparison - Children166
18-months - drinking alcohol
GroupValue95% CI
Substance Use Prevention Intervention51
Substance Use Prevention Intervention - Children30
Nutrition, Physical Activity, and Weight Talk Comparison36
Nutrition, Physical Activity, and Weight Talk Comparison - Children28
Substance Use Prevention Intervention106
Substance Use Prevention Intervention - Children121
Nutrition, Physical Activity, and Weight Talk Comparison124
Nutrition, Physical Activity, and Weight Talk Comparison - Children131
18-months - using e-cigarettes or vaping
GroupValue95% CI
Substance Use Prevention Intervention40
Substance Use Prevention Intervention - Children22
Nutrition, Physical Activity, and Weight Talk Comparison33
Nutrition, Physical Activity, and Weight Talk Comparison - Children18
Substance Use Prevention Intervention117
Substance Use Prevention Intervention - Children129
Nutrition, Physical Activity, and Weight Talk Comparison127
Nutrition, Physical Activity, and Weight Talk Comparison - Children141
18-months - using marijuana
GroupValue95% CI
Substance Use Prevention Intervention38
Substance Use Prevention Intervention - Children26
Nutrition, Physical Activity, and Weight Talk Comparison30
Nutrition, Physical Activity, and Weight Talk Comparison - Children22
Substance Use Prevention Intervention119
Substance Use Prevention Intervention - Children125
Nutrition, Physical Activity, and Weight Talk Comparison130
Nutrition, Physical Activity, and Weight Talk Comparison - Children137
Targeted Parent-child Communication on Substance Use Primary · 3 months (short-term) and 18 months (long-term)

An adapted version of the Targeted Parent-Child Communication about Alcohol Scale (Miller-Day et al, 2010) was used to assess targeted communication about alcohol and other drugs use. The ten-item assesses parents' agreement on having communication about substance use related topics and applying strategies parents may have discussed with their child. Items were assessed on a six-point Likert scale from "Strongly agree" to "Strongly disagree". Responses were dichotomized as "Agree" or "Strongly Agree" versus "Strongly Disagree" to "Somewhat Agree". This measure was reported by parents and chil

3 months - warned about the dangers
GroupValue95% CI
Substance Use Prevention Intervention162
Substance Use Prevention Intervention - Children147
Nutrition, Physical Activity, and Weight Talk Comparison126
Nutrition, Physical Activity, and Weight Talk Comparison - Children143
Substance Use Prevention Intervention19
Substance Use Prevention Intervention - Children34
Nutrition, Physical Activity, and Weight Talk Comparison59
Nutrition, Physical Activity, and Weight Talk Comparison - Children42
3 months - talked about how to handle offers
GroupValue95% CI
Substance Use Prevention Intervention137
Substance Use Prevention Intervention - Children125
Nutrition, Physical Activity, and Weight Talk Comparison81
Nutrition, Physical Activity, and Weight Talk Comparison - Children106
Substance Use Prevention Intervention44
Substance Use Prevention Intervention - Children56
Nutrition, Physical Activity, and Weight Talk Comparison104
Nutrition, Physical Activity, and Weight Talk Comparison - Children79
3 months - given rules to obey
GroupValue95% CI
Substance Use Prevention Intervention139
Substance Use Prevention Intervention - Children111
Nutrition, Physical Activity, and Weight Talk Comparison61
Nutrition, Physical Activity, and Weight Talk Comparison - Children104
Substance Use Prevention Intervention42
Substance Use Prevention Intervention - Children70
Nutrition, Physical Activity, and Weight Talk Comparison124
Nutrition, Physical Activity, and Weight Talk Comparison - Children81
3 months - not directly talked but given hints on not to use
GroupValue95% CI
Substance Use Prevention Intervention18
Substance Use Prevention Intervention - Children39
Nutrition, Physical Activity, and Weight Talk Comparison29
Nutrition, Physical Activity, and Weight Talk Comparison - Children59
Substance Use Prevention Intervention163
Substance Use Prevention Intervention - Children142
Nutrition, Physical Activity, and Weight Talk Comparison156
Nutrition, Physical Activity, and Weight Talk Comparison - Children126
3 months - lectured or given speech
GroupValue95% CI
Substance Use Prevention Intervention71
Substance Use Prevention Intervention - Children83
Nutrition, Physical Activity, and Weight Talk Comparison41
Nutrition, Physical Activity, and Weight Talk Comparison - Children68
Substance Use Prevention Intervention110
Substance Use Prevention Intervention - Children98
Nutrition, Physical Activity, and Weight Talk Comparison144
Nutrition, Physical Activity, and Weight Talk Comparison - Children117
3 months - made a comment if a character on TV is drinking/drunk
GroupValue95% CI
Substance Use Prevention Intervention83
Substance Use Prevention Intervention - Children84
Nutrition, Physical Activity, and Weight Talk Comparison57
Nutrition, Physical Activity, and Weight Talk Comparison - Children64
Substance Use Prevention Intervention98
Substance Use Prevention Intervention - Children97
Nutrition, Physical Activity, and Weight Talk Comparison128
Nutrition, Physical Activity, and Weight Talk Comparison - Children121
3 months - told stories of people who drink or have been drunk or use drugs
GroupValue95% CI
Substance Use Prevention Intervention112
Substance Use Prevention Intervention - Children60
Nutrition, Physical Activity, and Weight Talk Comparison86
Nutrition, Physical Activity, and Weight Talk Comparison - Children60
Substance Use Prevention Intervention69
Substance Use Prevention Intervention - Children121
Nutrition, Physical Activity, and Weight Talk Comparison99
Nutrition, Physical Activity, and Weight Talk Comparison - Children125
3 months - told they would be disappointed
GroupValue95% CI
Substance Use Prevention Intervention88
Substance Use Prevention Intervention - Children77
Nutrition, Physical Activity, and Weight Talk Comparison47
Nutrition, Physical Activity, and Weight Talk Comparison - Children71
Substance Use Prevention Intervention93
Substance Use Prevention Intervention - Children104
Nutrition, Physical Activity, and Weight Talk Comparison138
Nutrition, Physical Activity, and Weight Talk Comparison - Children114
Parent-child Audio-recorded Conversations About Substance Use Primary · 12 months

The prompts, modeled after the Family Assessment Task (FAsTask) where parents and adolescents have a conversation about substance use and related behaviors, were developed by the study team (Spirito et al, 2011). The same prompts are used at each time point. The sub-scales (expectations, messaging, communication style, and strategies) range from 1 to 9 (higher values represent a higher quality conversation compared to lower values). The overall combined score ranges from 4 to 36 (higher values represent a higher quality conversation compared to lower values).

Expectations
GroupValue95% CI
Substance Use Prevention Intervention3.5± 2.1
Nutrition, Physical Activity, and Weight Talk Comparison3.2± 1.9
Messaging
GroupValue95% CI
Substance Use Prevention Intervention4.7± 1.3
Nutrition, Physical Activity, and Weight Talk Comparison4.6± 1.3
Communication style
GroupValue95% CI
Substance Use Prevention Intervention5.5± 1.6
Nutrition, Physical Activity, and Weight Talk Comparison5.5± 1.5
Strategies
GroupValue95% CI
Substance Use Prevention Intervention2.4± 1.8
Nutrition, Physical Activity, and Weight Talk Comparison2.2± 1.5
Overall combined score
GroupValue95% CI
Substance Use Prevention Intervention16± 4.0
Nutrition, Physical Activity, and Weight Talk Comparison15.5± 3.5
Quality of Video-recorded Family Mealtime Interactions Primary · 12 months

The mean quality of mealtime interactions is measured using various scales from the Iowa Family Interaction Rating Scales (IFIRS) coding system: Dyadic Interaction Scales, Dyadic Relationship Scales, Group Interactions Scales, and Parenting Scales. Observed behaviors from 3 video-recorded family meals are assessed and scored on a 9-point scale. A higher score indicates coders observed a higher intensity and/or frequency of the construct in the video-recorded family meals. Each IFIRS scale is scored individually, and the average across the 3 family meals is reported. The items were organized in

Parent communication
GroupValue95% CI
Substance Use Prevention Intervention28.9± 0.3
Nutrition, Physical Activity, and Weight Talk Comparison28.6± 0.3
Parenting style
GroupValue95% CI
Substance Use Prevention Intervention30.3± 0.2
Nutrition, Physical Activity, and Weight Talk Comparison30.1± 0.2
Dyad relationship
GroupValue95% CI
Substance Use Prevention Intervention25.7± 0.3
Nutrition, Physical Activity, and Weight Talk Comparison25.8± 0.3
Group enjoyment
GroupValue95% CI
Substance Use Prevention Intervention4.5± 0.1
Nutrition, Physical Activity, and Weight Talk Comparison4.2± 0.1
Child Substance Use Expectancies (Alcohol) Primary · 18 months

Positive and negative expectancies about the affective, cognitive, and behavioral effects of alcohol use will be assessed with the Alcohol Expectancy Questionnaire-Adolescent Form, short version. The tool is comprised of 27 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. Questions 6, 9, 17, and 26 are scored in opposite direction before they are included in the negative sub-scale (remaining items are included in the positive sub-scale). Sub-scales are created by averaging the items and range from 1 to 6. A higher score on the positive expectancies sc

Positive expectancies
GroupValue95% CI
Substance Use Prevention Intervention - Children2.55± 0.08
Nutrition, Physical Activity, and Weight Talk Comparison - Children2.53± 0.07
Negative expectancies
GroupValue95% CI
Substance Use Prevention Intervention - Children4.24± 0.09
Nutrition, Physical Activity, and Weight Talk Comparison - Children4.23± 0.09
Child Substance Use Expectancies (Cigarettes) Primary · 18 months

Positive and negative expectancies about the affective, cognitive, and behavioral effects of cigarette use will be assessed with the Positive and Negative Outcome Expectancies of Smoking scale. The tool comprises 12 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. The tool has two subscales (positive expectancies, determined by 7 questions; negative expectancies, determined by 5 questions). Summary scores for both the positive and negative expectancies are created. Summary score values range from 0-7 for positive, 0-5 for negative expectancies. Higher

Positive expectancies
GroupValue95% CI
Substance Use Prevention Intervention - Children1.68± 0.05
Nutrition, Physical Activity, and Weight Talk Comparison - Children1.57± 0.05
Negative expectancies
GroupValue95% CI
Substance Use Prevention Intervention - Children5.15± 0.07
Nutrition, Physical Activity, and Weight Talk Comparison - Children5.22± 0.07
Child Substance Use Expectancies (Marijuana) Primary · 18 months

Positive and negative expectancies about the affective, cognitive, and behavioral effects of marijuana use will be assessed with an adapted version of the Marijuana Effect Expectancies Questionnaire - Brief. The tool comprises three standalone subscales (Relaxation/Tension Reduction, Cognitive/Behavioral Impairment, Global Negative Effects) for a total of 27 items. Each item has responses ranging from (1) Strongly Disagree to (6) Strongly Agree. Scores for each subscale are calculated by averaging item scores within that subscale. Each subscale score range is from 1 - 6. Higher scores on each

Positive expectancies
GroupValue95% CI
Substance Use Prevention Intervention - Children2.69± 0.1
Nutrition, Physical Activity, and Weight Talk Comparison - Children2.73± 0.1
Negative expectancies
GroupValue95% CI
Substance Use Prevention Intervention - Children4.04± 0.12
Nutrition, Physical Activity, and Weight Talk Comparison - Children4.16± 0.12
Child Affiliation With Substance-using Peers Primary · 18 months

Using an item from the Monitoring the Future study, children will be asked how many of their friends they think use substances. The item is repeated for each substance. This measure was reported by children only.

How many of your friends do you estimate occassionally drink alcohol?
GroupValue95% CI
Substance Use Prevention Intervention - Children21
Nutrition, Physical Activity, and Weight Talk Comparison - Children15
Substance Use Prevention Intervention - Children124
Nutrition, Physical Activity, and Weight Talk Comparison - Children126
How many of your friends do you think smoke cigarettes?
GroupValue95% CI
Substance Use Prevention Intervention - Children11
Nutrition, Physical Activity, and Weight Talk Comparison - Children4
Substance Use Prevention Intervention - Children137
Nutrition, Physical Activity, and Weight Talk Comparison - Children143
How many of your friends do you think use marijuana?
GroupValue95% CI
Substance Use Prevention Intervention - Children15
Nutrition, Physical Activity, and Weight Talk Comparison - Children11
Substance Use Prevention Intervention - Children131
Nutrition, Physical Activity, and Weight Talk Comparison - Children137
How many of your friends do you estimate occassionally use e-cigarettes or vapes?
GroupValue95% CI
Substance Use Prevention Intervention - Children29
Nutrition, Physical Activity, and Weight Talk Comparison - Children23
Substance Use Prevention Intervention - Children117
Nutrition, Physical Activity, and Weight Talk Comparison - Children119
How many of your friends do you think use other drugs?
GroupValue95% CI
Substance Use Prevention Intervention - Children4
Nutrition, Physical Activity, and Weight Talk Comparison - Children2
Substance Use Prevention Intervention - Children140
Nutrition, Physical Activity, and Weight Talk Comparison - Children139
Child Willingness to Use Substances Primary · 18 months

Child willingness to use substances will be assessed through three items adapted from the measure combining intention and willingness originally developed for tobacco and amphetamines found in Gibbons et al. (1998) Reasoned Action and Social Reaction: Willingness and Intention as Independent Predictors of Health Risk. The three items will be asked for each substance. Each item has response options ranging from (1) Not at all likely to (6) Very likely. Response options are transformed to binary format such that 0 represents (1) Not at all likely and 1 represents (2) Unlikely to (6) Very Likely.

Alcohol - Willingness to use
GroupValue95% CI
Substance Use Prevention Intervention - Children0.27± 0.64
Nutrition, Physical Activity, and Weight Talk Comparison - Children0.26± 0.63
Cigarettes - Willingness to use
GroupValue95% CI
Substance Use Prevention Intervention - Children0.22± 0.61
Nutrition, Physical Activity, and Weight Talk Comparison - Children0.13± 0.41
Cannabis - Willingness to use
GroupValue95% CI
Substance Use Prevention Intervention - Children0.24± 0.66
Nutrition, Physical Activity, and Weight Talk Comparison - Children0.15± 0.45
E-cigarettes or vaping - Willingness to use
GroupValue95% CI
Substance Use Prevention Intervention - Children0.34± 0.85
Nutrition, Physical Activity, and Weight Talk Comparison - Children0.21± 0.56
Other drugs - Willingness to use
GroupValue95% CI
Substance Use Prevention Intervention - Children0.12± 0.44
Nutrition, Physical Activity, and Weight Talk Comparison - Children0.17± 0.49
Child Intentions to Use Substances Primary · 18 months

One item from the Youth Alcohol and Drug Survey will assess child's intention to use substances in the next 30 days. The question is asked for each substance and has the response options 'No', 'Probably No', 'Probably Yes', 'Yes'. Response options are dichotomized to (1) No \[which includes 'No' and 'Probably No'\] and (2) Yes \[which includes 'Probably Yes' and 'Yes'\]. This measure was reported by children only.

Alcohol - Plan to use in the next 30 days
GroupValue95% CI
Substance Use Prevention Intervention - Children0
Nutrition, Physical Activity, and Weight Talk Comparison - Children0
Substance Use Prevention Intervention - Children147
Nutrition, Physical Activity, and Weight Talk Comparison - Children146
Cigarettes - Plan to use in the next 30 days
GroupValue95% CI
Substance Use Prevention Intervention - Children0
Nutrition, Physical Activity, and Weight Talk Comparison - Children0
Substance Use Prevention Intervention - Children147
Nutrition, Physical Activity, and Weight Talk Comparison - Children148
Cannabis - Plan to use in the next 30 days
GroupValue95% CI
Substance Use Prevention Intervention - Children0
Nutrition, Physical Activity, and Weight Talk Comparison - Children0
Substance Use Prevention Intervention - Children147
Nutrition, Physical Activity, and Weight Talk Comparison - Children147
E-cigarettes or vapes - Plan to use in the next 30 days
GroupValue95% CI
Substance Use Prevention Intervention - Children1
Nutrition, Physical Activity, and Weight Talk Comparison - Children1
Substance Use Prevention Intervention - Children146
Nutrition, Physical Activity, and Weight Talk Comparison - Children147
Other drugs - Plan to use in the next 30 days
GroupValue95% CI
Substance Use Prevention Intervention - Children0
Nutrition, Physical Activity, and Weight Talk Comparison - Children0
Substance Use Prevention Intervention - Children144
Nutrition, Physical Activity, and Weight Talk Comparison - Children140
Pre/Early-adolescent Substance Use Initiation Secondary · 18 months

Substance use initiation for each substance will be assessed with three items from the Drug Use Questionnaire. The items will be asked for each substance. Child responds Yes/No to the "have you ever used \[substance\]?" question. This measure was reported by children only.

Alcohol
GroupValue95% CI
Substance Use Prevention Intervention - Children14
Nutrition, Physical Activity, and Weight Talk Comparison - Children9
Substance Use Prevention Intervention - Children173
Nutrition, Physical Activity, and Weight Talk Comparison - Children173
Cigarettes
GroupValue95% CI
Substance Use Prevention Intervention - Children3
Nutrition, Physical Activity, and Weight Talk Comparison - Children2
Substance Use Prevention Intervention - Children184
Nutrition, Physical Activity, and Weight Talk Comparison - Children180
Cannabis
GroupValue95% CI
Substance Use Prevention Intervention - Children9
Nutrition, Physical Activity, and Weight Talk Comparison - Children3
Substance Use Prevention Intervention - Children178
Nutrition, Physical Activity, and Weight Talk Comparison - Children179
E-cigarettes or vaping
GroupValue95% CI
Substance Use Prevention Intervention - Children13
Nutrition, Physical Activity, and Weight Talk Comparison - Children6
Substance Use Prevention Intervention - Children174
Nutrition, Physical Activity, and Weight Talk Comparison - Children176
Other drugs
GroupValue95% CI
Substance Use Prevention Intervention - Children1
Nutrition, Physical Activity, and Weight Talk Comparison - Children1
Substance Use Prevention Intervention - Children186
Nutrition, Physical Activity, and Weight Talk Comparison - Children181

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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).
    Skeer MR, Sabelli RA, Rancaño KM, Lee-Bravatti M, et al · · 2022 · cited 6× · PMID 35108294 · DOI 10.1371/journal.pone.0263016
  2. Efficacy of a Universal Weight Stigma Intervention on the Quality of Parent-Child Conversations About Weight.
    Rancaño KM, Skeer M, Puhl R, Eliasziw M, et al · · 2025 · cited 1× · PMID 39903139 · DOI 10.1016/j.jadohealth.2024.11.012

Verify or expand the search:

Other recruiting trials for Substance-Related Disorders

Currently open trials in the same condition.

Other Tufts University trials

Trials by the same sponsor.

Verify against primary sources

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/NCT03925220.

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