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| Name | Class |
|---|---|
| Brown University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substance Use Prevention Intervention | Experimental | 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. |
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| Nutrition, Physical Activity, and Weight Talk Comparison | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The SUPPER Project | Behavioral | Substance Use Promoted by Eating family meals Regularly |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 12 months |
| Quality of Video-recorded Family Mealtime Interactions |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margie Skeer, ScD, MPH, MSW | Tufts University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Medicine | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35108294 | Derived | 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. |
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Participants were screened for eligibility and had to complete all baseline assessments. Parents and children were eligible to participate if: (1) the child was enrolled in 5th, 6th, or 7th grade at a school within Massachusetts at the time of recruitment, (2) the child and parent were able to independently complete study activities in English or Spanish, (3) the parent and child were living together at least 50% of the time, (4) parents consent to participate and child gives assent.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Substance Use Prevention Intervention - Parents | Parents were given a handbook specific to the gender of their child that provides information and advice on communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2018 | Mar 31, 2025 |
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| Improving nutrition and physical activity among youth | Behavioral | A brief intervention focused on improving nutrition and physical activity among youth |
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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). |
| 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. | 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. | 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. | 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. | 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. | 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. | 18 months |
| FG001 | Substance Use Prevention Intervention - Children | Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. |
| FG002 | Nutrition, Physical Activity, and Weight Talk Comparison - Parents | Parents received 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 also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had 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. |
| FG003 | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Children discussed with their parents 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. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert. |
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| Baseline Analyzed | The number of participants who completed baseline and one or more follow-up surveys. |
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| 3 Months Follow-up |
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| 6 Months Follow-up |
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| 12 Months Follow-up |
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| 18 Months Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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The overall number of participants at baseline includes parent and child participants who completed one or more post-randomization surveys.
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| ID | Title | Description |
|---|---|---|
| BG000 | Substance Use Prevention Intervention | Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. |
| BG001 | Substance Use Prevention Intervention - Children | Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. |
| BG002 | Nutrition, Physical Activity, and Weight Talk Comparison | For the comparison condition, after the baseline assessment, parents received 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 also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had 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. |
| BG003 | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Children discussed with their parents 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. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was calculated by date of birth and date of survey completion. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Sex was measured by asking about biological sex assigned at birth. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity was measured by asking "Do you consider yourself Hispanic or Latino/a?". | Count of Participants | Participants |
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| Race (NIH/OMB) | Race was measured by asking "Which of the following best describes you?". | Count of Participants | Participants |
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| Region of Enrollment | Participants were asked in which school district the child attends school. | Count of Participants | Participants |
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| 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". | Missing participants did not answer the survey question. | Count of Participants | Participants |
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| 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". | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Sample sizes differ for parent- and child-reported data based on how many parents and children completed the survey at each follow-up. | Posted | Count of Participants | Participants | 3 months (short-term) and 18 months (long-term) |
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| Primary | 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. | Sample sizes differ for parent- and child-reported data based on how many parents and children completed the survey at each follow-up. | Posted | Count of Participants | Participants | 3 months (short-term) and 18 months (long-term) |
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| Primary | 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). | Sample sizes differ at each follow-up based on how many parents and children completed the audio submission. | Posted | Mean | Standard Deviation | score | 12 months |
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| Primary | 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). | Sample sizes differ at each follow-up based on how many parents and children completed the video submission. | Posted | Mean | Standard Deviation | score | 12 months |
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| Primary | 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. | Sample sizes differ based on how many children completed the survey at each follow-up. | Posted | Mean | Standard Deviation | score | 18 months |
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| Primary | 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. | Sample sizes differ based on how many children completed the survey at each follow-up. | Posted | Mean | Standard Error | score | 18 months |
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| Primary | 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. | Sample sizes differ based on how many children completed the survey at each follow-up. | Posted | Mean | Standard Error | score | 18 months |
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| Primary | 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. | Sample sizes differ based on how many children completed the survey at each follow-up. | Posted | Count of Participants | Participants | 18 months |
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| Primary | 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. | Sample sizes differ based on how many children completed the survey at each follow-up. | Posted | Mean | Standard Deviation | score | 18 months |
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| Primary | 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. | Sample sizes differ based on how many children completed the survey at each follow-up. | Posted | Count of Participants | Participants | 18 months |
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| Secondary | 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. | Sample sizes differ based on how many children completed the survey at each follow-up. | Posted | Count of Participants | Participants | 18 months |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Substance Use Prevention Intervention - Parents | Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. The SUPPER Project: Substance Use Promoted by Eating family meals Regularly | 0 | 201 | 0 | 201 | 0 | 201 |
| EG001 | Substance Use Prevention Intervention - Children | Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. | 0 | 201 | 0 | 201 | 0 | 201 |
| EG002 | Nutrition, Physical Activity, and Weight Talk Comparison - Parents | For the comparison condition, after the baseline assessment, parents received 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 also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had 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. Improving nutrition and physical activity among youth: A brief intervention focused on improving nutrition and physical activity among youth | 0 | 201 | 0 | 201 | 0 | 201 |
| EG003 | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Children discussed with their parents 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. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert. | 0 | 201 | 0 | 201 | 0 | 201 |
Not provided
Not provided
It was hypothesized a priori that the intervention's effects would not be able to be determined through differences in child-reported substance use outcomes, since the prevalence of substance use in this age group is historically very low.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margie Skeer | Tufts University | 8579191262 | margie.skeer@tufts.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2018 | Mar 31, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 5, 2020 | Mar 31, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000066608 | Underage Drinking |
| D000294 | Adolescent Behavior |
| D003142 | Communication |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 'None', 'once', or 'a few times' |
|
| On smoking cigarettes |
|
| On using cannabis |
|
| On vaping |
|
| On using other drugs |
|
| Disagree |
|
| Talked about how to handle offers |
|
| Given rules to obey |
|
| Not directly talked but given hints |
|
| Lectured or given speech |
|
| Made a comment on character on TV |
|
| Told stories of people |
|
| Told they would be disappointed |
|
| Shown information about the dangers |
|
| Asked about their thoughts/opinions |
|
|
| 3-months - using e-cigarettes or vaping |
|
|
| 3-months - using marijuana |
|
|
| 3-months - smoking cigarettes |
|
|
| 3-months - using other drugs |
|
|
| 18-months - drinking alcohol |
|
|
| 18-months - using e-cigarettes or vaping |
|
|
| 18-months - using marijuana |
|
|
| 18-months - smoking cigarettes |
|
|
| 18-months - using other drugs |
|
|
| Generalized estimation | <0.001 | At 3 months: Parent-reported frequency of conversations on using e-cigarettes or vaping | Prevalence Ratio [PR] | 2.4 | 2-Sided | 95 | 1.67 | 3.45 | Superiority |
| Generalized estimation | <0.001 | At 3 months: Parent-reported frequency of conversations on using marijuana | Prevalence Ratio [PR] | 2.36 | 2-Sided | 95 | 1.62 | 3.43 | Superiority |
| Generalized estimation | <0.001 | At 3 months: Parent-reported frequency of conversations on smoking cigarettes | Prevalence Ratio [PR] | 3.45 | 2-Sided | 95 | 2.34 | 5.08 | Superiority |
| Generalized estimation | <0.001 | At 3 months: Parent-reported frequency of conversations on using other drugs | Prevalence Ratio [PR] | 2.47 | 2-Sided | 95 | 1.58 | 3.86 | Superiority |
| Generalized estimation | 0.04 | At 18 months: Parent-reported frequency of conversations on drinking alcohol | Prevalence Ratio [PR] | 1.45 | 2-Sided | 95 | 1.02 | 2.06 | Superiority |
| OG001 | Substance Use Prevention Intervention - Children | Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. |
| OG002 | Nutrition, Physical Activity, and Weight Talk Comparison | For the comparison condition, after the baseline assessment, parents received 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 also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had 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. |
| OG003 | Nutrition, Physical Activity, and Weight Talk Comparison - Children | Children discussed with their parents 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. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert. |
|
|
|
| OG001 | Nutrition, Physical Activity, and Weight Talk Comparison | For the comparison condition, after the baseline assessment, parents received 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 also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had 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. |
|
|
| OG001 | Nutrition, Physical Activity, and Weight Talk Comparison | For the comparison condition, after the baseline assessment, parents received 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 also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had 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. |
|
|
| Nutrition, Physical Activity, and Weight Talk Comparison - Children |
Children discussed with their parents 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. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert. |
|
|
| OG001 | Nutrition, Physical Activity, and Weight Talk Comparison - Children | For the comparison condition, after the baseline assessment, parents received 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 also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had 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. |
|
|
| OG001 |
| Nutrition, Physical Activity, and Weight Talk Comparison - Children |
Children discussed with their parents 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. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert. |
|
|
|
|
| Nutrition, Physical Activity, and Weight Talk Comparison - Children |
Children discussed with their parents 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. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert. |
|
|
|
|
|
|
| 'None', 'once', or 'a few times' |
|
| 'None', 'once', or 'a few times' |
|
| 'None', 'once', or 'a few times' |
|
| 'None', 'once', or 'a few times' |
|
| 'None', 'once', or 'a few times' |
|
| 'None', 'once', or 'a few times' |
|
| 'None', 'once', or 'a few times' |
|
| 'None', 'once', or 'a few times' |
|
| 'None', 'once', or 'a few times' |
|
| Disagree |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| None |
|
| None |
|
| None |
|
| None |
|
| No |
|
| No |
|
| No |
|
| No |
|