An interventional study of The SUPPER Project and Improving nutrition and physical activity among youth in Substance-Related Disorders, Underage Drinking and Drug Use, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Tufts University · Not applicable, Interventional, and Prevention
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.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's enrollment of 402 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: The SUPPER Project
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.
Behavioral: Improving nutrition and physical activity among youth
Substance Use Promoted by Eating family meals Regularly
A brief intervention focused on improving nutrition and physical activity among youth
Frequency of Parent-child Conversations on Substances
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.
Time frame: 3 months (short-term) and 18 months (long-term)
Targeted Parent-child Communication on Substance Use
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 children.
Time frame: 3 months (short-term) and 18 months (long-term)
Parent-child Audio-recorded Conversations About Substance Use
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).
Time frame: 12 months
Quality of Video-recorded Family Mealtime Interactions
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 into four subscales: Communication (range: 4-36), Parenting Style (range: 5-45), Dyad Relationship (range: 5-45), and Group Enjoyment (range: 1-9).
Time frame: 12 months
Child Substance Use Expectancies (Alcohol)
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 scale indicates a greater belief that alcohol has desirable effects, and a higher score on the negative expectancies scale indicates a greater belief that alcohol has undesirable effects. This measure was reported by children only.
Time frame: 18 months
Child Substance Use Expectancies (Cigarettes)
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 score on positive expectancies scale indicates a greater belief that there are positive outcomes of smoking. Higher score on negative expectancies scale indicates a greater belief in negative consequences of smoking. This measure was reported by children only.
Time frame: 18 months
Child Substance Use Expectancies (Marijuana)
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 scale indicate greater expectations positive expectancies (Relaxation/Tension Reduction) and negative expectancies (Cognitive/Behavioral Impairment and Global Negative Effects) associated with marijuana use. This measure was reported by children only.
Time frame: 18 months
Child Affiliation With Substance-using Peers
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.
Time frame: 18 months
Child Willingness to Use Substances
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. The three binary items are then averaged for each substance and scores range from 0 to 1 (0 being not willing at all and 1 being somewhat to very likely willing to use the substance). This measure was reported by children only.
Time frame: 18 months
Child Intentions to Use Substances
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.
Time frame: 18 months
Pre/Early-adolescent Substance Use Initiation
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.
Time frame: 18 months
The protocol enrollment reflects the number of parent and child dyads enrolled in the study. Before COVID-19, participants were recruited through schools. After COVID-19, participants were recruited through community-based organizations and an online recruitment company.
| Milestone | Substance Use Prevention Intervention - Parents | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison - Parents | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|---|---|
| Started | 201 | 201 | 201 | 201 |
| Baseline analyzed | 192 | 192 | 196 | 196 |
| 3 months follow-up | 181 | 181 | 185 | 185 |
| 6 months follow-up | 159 | 159 | 170 | 170 |
| 12 months follow-up | 152 | 148 | 150 | 150 |
| 18 months follow-up | 157 | 151 | 160 | 159 |
| Completed | 157 | 151 | 160 | 159 |
| Not completed | 44 | 50 | 41 | 42 |
| Withdrew: Withdrawal by subject | 4 | 4 | 4 | 4 |
| Withdrew: Lost to follow-up | 40 | 46 | 37 | 38 |
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.
| Participants | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|---|---|
| 3-months - drinking alcohol — 'Several times' or 'a lot' | 87 | 32 | 29 | 20 |
| 3-months - drinking alcohol — 'None', 'once', or 'a few times' | 91 | 146 | 156 | 165 |
| 3-months - using e-cigarettes or vaping — 'Several times' or 'a lot' | 70 | 28 | 28 | 17 |
| 3-months - using e-cigarettes or vaping — 'None', 'once', or 'a few times' | 108 | 150 | 157 | 168 |
| 3-months - using marijuana — 'Several times' or 'a lot' | 61 | 20 | 27 | 17 |
| 3-months - using marijuana — 'None', 'once', or 'a few times' | 117 | 158 | 158 | 168 |
| 3-months - smoking cigarettes — 'Several times' or 'a lot' | 79 | 28 | 23 | 21 |
| 3-months - smoking cigarettes — 'None', 'once', or 'a few times' | 99 | 150 | 162 | 164 |
| 3-months - using other drugs — 'Several times' or 'a lot' | 55 | 25 | 20 | 19 |
| 3-months - using other drugs — 'None', 'once', or 'a few times' | 123 | 153 | 165 | 166 |
| 18-months - drinking alcohol — 'Several times' or 'a lot' | 51 | 30 | 36 | 28 |
| 18-months - drinking alcohol — 'None', 'once', or 'a few times' | 106 | 121 | 124 | 131 |
| 18-months - using e-cigarettes or vaping — 'Several times' or 'a lot' | 40 | 22 | 33 | 18 |
| 18-months - using e-cigarettes or vaping — 'None', 'once', or 'a few times' | 117 | 129 | 127 | 141 |
| 18-months - using marijuana — 'Several times' or 'a lot' | 38 | 26 | 30 | 22 |
| 18-months - using marijuana — 'None', 'once', or 'a few times' | 119 | 125 | 130 | 137 |
| 18-months - smoking cigarettes — 'Several times' or 'a lot' | 33 | 22 | 28 | 18 |
| 18-months - smoking cigarettes — 'None', 'once', or 'a few times' | 124 | 129 | 132 | 141 |
| 18-months - using other drugs — 'Several times' or 'a lot' | 28 | 23 | 26 | 19 |
| 18-months - using other drugs — 'None', 'once', or 'a few times' | 129 | 128 | 134 | 140 |
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 children.
| Participants | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|---|---|
| 3 months - warned about the dangers — Agree | 162 | 147 | 126 | 143 |
| 3 months - warned about the dangers — Disagree | 19 | 34 | 59 | 42 |
| 3 months - talked about how to handle offers — Agree | 137 | 125 | 81 | 106 |
| 3 months - talked about how to handle offers — Disagree | 44 | 56 | 104 | 79 |
| 3 months - given rules to obey — Agree | 139 | 111 | 61 | 104 |
| 3 months - given rules to obey — Disagree | 42 | 70 | 124 | 81 |
| 3 months - not directly talked but given hints on not to use — Agree | 18 | 39 | 29 | 59 |
| 3 months - not directly talked but given hints on not to use — Disagree | 163 | 142 | 156 | 126 |
| 3 months - lectured or given speech — Agree | 71 | 83 | 41 | 68 |
| 3 months - lectured or given speech — Disagree | 110 | 98 | 144 | 117 |
| 3 months - made a comment if a character on TV is drinking/drunk — Agree | 83 | 84 | 57 | 64 |
| 3 months - made a comment if a character on TV is drinking/drunk — Disagree | 98 | 97 | 128 | 121 |
| 3 months - told stories of people who drink or have been drunk or use drugs — Agree | 112 | 60 | 86 | 60 |
| 3 months - told stories of people who drink or have been drunk or use drugs — Disagree | 69 | 121 | 99 | 125 |
| 3 months - told they would be disappointed — Agree | 88 | 77 | 47 | 71 |
| 3 months - told they would be disappointed — Disagree | 93 | 104 | 138 | 114 |
| 3 months - shown information about the dangers — Agree | 71 | 50 | 48 | 44 |
| 3 months - shown information about the dangers — Disagree | 110 | 131 | 137 | 141 |
| 3 months - asked about their thoughts or opinions — Agree | 144 | 101 | 83 | 81 |
| 3 months - asked about their thoughts or opinions — Disagree | 37 | 80 | 102 | 104 |
| 18 months - warned about the dangers — Agree | 114 | 108 | 105 | 108 |
| 18 months - warned about the dangers — Disagree | 43 | 43 | 55 | 51 |
| 18 months - talked about how to handle offers — Agree | 95 | 93 | 76 | 81 |
| 18 months - talked about how to handle offers — Disagree | 62 | 58 | 84 | 78 |
| 18 months - given rules to obey — Agree | 87 | 92 | 63 | 74 |
| 18 months - given rules to obey — Disagree | 70 | 59 | 97 | 85 |
| 18 months - not directly talked but given hints on not to use — Agree | 18 | 22 | 27 | 49 |
| 18 months - not directly talked but given hints on not to use — Disagree | 139 | 129 | 133 | 110 |
| 18 months - lectured or given speech — Agree | 50 | 62 | 32 | 47 |
| 18 months - lectured or given speech — Disagree | 107 | 89 | 128 | 112 |
| 18 months - made a comment if a character on TV is drinking/drunk — Agree | 69 | 47 | 50 | 52 |
| 18 months - made a comment if a character on TV is drinking/drunk — Disagree | 88 | 104 | 110 | 107 |
| 18 months - told stories of people who drink or have been drunk or use drugs — Agree | 90 | 55 | 76 | 52 |
| 18 months - told stories of people who drink or have been drunk or use drugs — Disagree | 67 | 96 | 84 | 107 |
| 18 months - told they would be disappointed — Agree | 56 | 59 | 41 | 52 |
| 18 months - told they would be disappointed — Disagree | 101 | 92 | 119 | 107 |
| 18 months - shown information about the dangers — Agree | 56 | 36 | 38 | 37 |
| 18 months - shown information about the dangers — Disagree | 101 | 115 | 122 | 122 |
| 18 months - asked about their thoughts or opinions — Agree | 99 | 64 | 84 | 57 |
| 18 months - asked about their thoughts or opinions — Disagree | 58 | 87 | 76 | 102 |
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).
| score | Substance Use Prevention Intervention | Nutrition, Physical Activity, and Weight Talk Comparison |
|---|---|---|
| Expectations | 3.5 ± 2.1 | 3.2 ± 1.9 |
| Messaging | 4.7 ± 1.3 | 4.6 ± 1.3 |
| Communication style | 5.5 ± 1.6 | 5.5 ± 1.5 |
| Strategies | 2.4 ± 1.8 | 2.2 ± 1.5 |
| Overall combined score | 16 ± 4.0 | 15.5 ± 3.5 |
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 into four subscales: Communication (range: 4-36), Parenting Style (range: 5-45), Dyad Relationship (range: 5-45), and Group Enjoyment (range: 1-9).
| score | Substance Use Prevention Intervention | Nutrition, Physical Activity, and Weight Talk Comparison |
|---|---|---|
| Parent communication | 28.9 ± 0.3 | 28.6 ± 0.3 |
| Parenting style | 30.3 ± 0.2 | 30.1 ± 0.2 |
| Dyad relationship | 25.7 ± 0.3 | 25.8 ± 0.3 |
| Group enjoyment | 4.5 ± 0.1 | 4.2 ± 0.1 |
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 scale indicates a greater belief that alcohol has desirable effects, and a higher score on the negative expectancies scale indicates a greater belief that alcohol has undesirable effects. This measure was reported by children only.
| score | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|
| Positive expectancies | 2.55 ± 0.08 | 2.53 ± 0.07 |
| Negative expectancies | 4.24 ± 0.09 | 4.23 ± 0.09 |
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 score on positive expectancies scale indicates a greater belief that there are positive outcomes of smoking. Higher score on negative expectancies scale indicates a greater belief in negative consequences of smoking. This measure was reported by children only.
| score | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|
| Positive expectancies | 1.68 ± 0.05 | 1.57 ± 0.05 |
| Negative expectancies | 5.15 ± 0.07 | 5.22 ± 0.07 |
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 scale indicate greater expectations positive expectancies (Relaxation/Tension Reduction) and negative expectancies (Cognitive/Behavioral Impairment and Global Negative Effects) associated with marijuana use. This measure was reported by children only.
| score | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|
| Positive expectancies | 2.69 ± 0.1 | 2.73 ± 0.1 |
| Negative expectancies | 4.04 ± 0.12 | 4.16 ± 0.12 |
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.
| Participants | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|
| How many of your friends do you estimate occassionally drink alcohol? — Some to most | 21 | 15 |
| How many of your friends do you estimate occassionally drink alcohol? — None | 124 | 126 |
| How many of your friends do you think smoke cigarettes? — Some to most | 11 | 4 |
| How many of your friends do you think smoke cigarettes? — None | 137 | 143 |
| How many of your friends do you think use marijuana? — Some to most | 15 | 11 |
| How many of your friends do you think use marijuana? — None | 131 | 137 |
| How many of your friends do you estimate occassionally use e-cigarettes or vapes? — Some to most | 29 | 23 |
| How many of your friends do you estimate occassionally use e-cigarettes or vapes? — None | 117 | 119 |
| How many of your friends do you think use other drugs? — Some to most | 4 | 2 |
| How many of your friends do you think use other drugs? — None | 140 | 139 |
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. The three binary items are then averaged for each substance and scores range from 0 to 1 (0 being not willing at all and 1 being somewhat to very likely willing to use the substance). This measure was reported by children only.
| score | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|
| Alcohol - Willingness to use | 0.27 ± 0.64 | 0.26 ± 0.63 |
| Cigarettes - Willingness to use | 0.22 ± 0.61 | 0.13 ± 0.41 |
| Cannabis - Willingness to use | 0.24 ± 0.66 | 0.15 ± 0.45 |
| E-cigarettes or vaping - Willingness to use | 0.34 ± 0.85 | 0.21 ± 0.56 |
| Other drugs - Willingness to use | 0.12 ± 0.44 | 0.17 ± 0.49 |
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.
| Participants | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|
| Alcohol - Plan to use in the next 30 days — Yes | 0 | 0 |
| Alcohol - Plan to use in the next 30 days — No | 147 | 146 |
| Cigarettes - Plan to use in the next 30 days — Yes | 0 | 0 |
| Cigarettes - Plan to use in the next 30 days — No | 147 | 148 |
| Cannabis - Plan to use in the next 30 days — Yes | 0 | 0 |
| Cannabis - Plan to use in the next 30 days — No | 147 | 147 |
| E-cigarettes or vapes - Plan to use in the next 30 days — Yes | 1 | 1 |
| E-cigarettes or vapes - Plan to use in the next 30 days — No | 146 | 147 |
| Other drugs - Plan to use in the next 30 days — Yes | 0 | 0 |
| Other drugs - Plan to use in the next 30 days — No | 144 | 140 |
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.
| Participants | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison - Children |
|---|---|---|
| Alcohol — Yes | 14 | 9 |
| Alcohol — No | 173 | 173 |
| Cigarettes — Yes | 3 | 2 |
| Cigarettes — No | 184 | 180 |
| Cannabis — Yes | 9 | 3 |
| Cannabis — No | 178 | 179 |
| E-cigarettes or vaping — Yes | 13 | 6 |
| E-cigarettes or vaping — No | 174 | 176 |
| Other drugs — Yes | 1 | 1 |
| Other drugs — No | 186 | 181 |
Collected over Adverse event data were collected over 24 months (from randomization through study completion date) for parent and child participants, and no adverse events were reported.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Substance Use Prevention Intervention - Parents | 0/201 (0%) | 0/201 (0%) | 0/201 (0%) |
| Substance Use Prevention Intervention - Children | 0/201 (0%) | 0/201 (0%) | 0/201 (0%) |
| Nutrition, Physical Activity, and Weight Talk Comparison - Parents | 0/201 (0%) | 0/201 (0%) | 0/201 (0%) |
| Nutrition, Physical Activity, and Weight Talk Comparison - Children | 0/201 (0%) | 0/201 (0%) | 0/201 (0%) |
The overall number of participants at baseline includes parent and child participants who completed one or more post-randomization surveys.
| Age, Continuous(years) | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Total |
|---|---|---|---|---|---|
| Mean | 42.1 ± 6.3 | 11.8 ± 1.1 | 43.3 ± 6.8 | 11.8 ± 1.0 | 27.3 ± 3.8 |
| Sex: Female, Male(Participants) | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Total |
|---|---|---|---|---|---|
| Female | 169 | 99 | 173 | 102 | 543 |
| Male | 23 | 93 | 23 | 94 | 233 |
| Ethnicity (NIH/OMB)(Participants) | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 41 | 48 | 40 | 42 | 171 |
| Not Hispanic or Latino | 151 | 144 | 156 | 154 | 605 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 8 | 9 | 7 | 4 | 28 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 | 1 | 3 |
| Black or African American | 19 | 21 | 26 | 28 | 94 |
| White | 117 | 104 | 118 | 110 | 449 |
| More than one race | 7 | 9 | 4 | 11 | 31 |
| Unknown or Not Reported | 41 | 48 | 40 | 42 | 171 |
| Region of Enrollment(Participants) | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Total |
|---|---|---|---|---|---|
| United States | 192 | 192 | 196 | 196 | 776 |
| Frequency of parent-child conversations on substances(Participants) | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Total |
|---|---|---|---|---|---|
| On drinking alcohol — 'Several times' or 'a lot' | 28 | 17 | 36 | 23 | 104 |
| On drinking alcohol — 'None', 'once', or 'a few times' | 164 | 175 | 160 | 173 | 672 |
| On smoking cigarettes — 'Several times' or 'a lot' | 23 | 12 | 26 | 19 | 80 |
| On smoking cigarettes — 'None', 'once', or 'a few times' | 169 | 180 | 170 | 177 | 696 |
| On using cannabis — 'Several times' or 'a lot' | 16 | 14 | 27 | 18 | 75 |
| On using cannabis — 'None', 'once', or 'a few times' | 176 | 178 | 169 | 178 | 701 |
| On vaping — 'Several times' or 'a lot' | 19 | 14 | 31 | 13 | 77 |
| On vaping — 'None', 'once', or 'a few times' | 173 | 178 | 165 | 183 | 699 |
| On using other drugs — 'Several times' or 'a lot' | 23 | 17 | 23 | 25 | 88 |
| On using other drugs — 'None', 'once', or 'a few times' | 169 | 175 | 173 | 171 | 688 |
| Targeted parent-child communication on substance use(Participants) | Substance Use Prevention Intervention | Substance Use Prevention Intervention - Children | Nutrition, Physical Activity, and Weight Talk Comparison | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Total |
|---|---|---|---|---|---|
| Warned about the dangers — Agree | 142 | 164 | 157 | 168 | 631 |
| Warned about the dangers — Disagree | 50 | 28 | 39 | 28 | 145 |
| Talked about how to handle offers — Agree | 81 | 122 | 88 | 116 | 407 |
| Talked about how to handle offers — Disagree | 111 | 70 | 108 | 80 | 369 |
| Given rules to obey — Agree | 72 | 115 | 82 | 111 | 380 |
| Given rules to obey — Disagree | 120 | 77 | 114 | 85 | 396 |
| Not directly talked but given hints — Agree | 44 | 58 | 41 | 64 | 207 |
| Not directly talked but given hints — Disagree | 148 | 134 | 155 | 132 | 569 |
| Lectured or given speech — Agree | 69 | 84 | 66 | 88 | 307 |
| Lectured or given speech — Disagree | 123 | 108 | 130 | 108 | 469 |
| Made a comment on character on TV — Agree | 69 | 70 | 78 | 73 | 290 |
| Made a comment on character on TV — Disagree | 123 | 122 | 118 | 123 | 486 |
| Told stories of people — Agree | 104 | 58 | 104 | 75 | 341 |
| Told stories of people — Disagree | 88 | 134 | 92 | 121 | 435 |
| Told they would be disappointed — Agree | 49 | 91 | 57 | 95 | 292 |
| Told they would be disappointed — Disagree | 143 | 101 | 139 | 101 | 484 |
| Shown information about the dangers — Agree | 53 | 50 | 47 | 59 | 209 |
| Shown information about the dangers — Disagree | 139 | 142 | 149 | 137 | 567 |
| Asked about their thoughts/opinions — Agree | 102 | 106 | 107 | 115 | 430 |
| Asked about their thoughts/opinions — Disagree | 90 | 86 | 89 | 81 | 346 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.