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

NCT03925220 | Completed Results

• 1 other identifier: 1R01DA045073-01A1
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to test the efficacy of a family communication-based, novel, adaptable, and resource-efficient substance misuse preventive intervention for parents/guardians of pre/early adolescents (grades 5-7). The short-term goal of this study is to increase the quality time that parents spend with their children through eating meals together, and in so doing, talking about the harms associated with substance use (intermediate endpoint), which will in turn, lead to the long-term goal of preventing the initiation and misuse of substances among their children as they enter adolescence.

Conditions

Substance-Related Disorders; Underage Drinking; Drug Use

Keywords

Primary Prevention; Adolescent Behavior; Family; Personal Communication

Outcome Measures

Primary Outcomes (10)

• 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

  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

Secondary Outcomes (1)

• Pre/Early-adolescent Substance Use Initiation

  18 months

Study Arms (2)

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.

Behavioral: The SUPPER Project

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.

Behavioral: Improving nutrition and physical activity among youth

Interventions

The SUPPER Project BEHAVIORAL

Substance Use Promoted by Eating family meals Regularly

Substance Use Prevention Intervention

Improving nutrition and physical activity among youth BEHAVIORAL

A brief intervention focused on improving nutrition and physical activity among youth

Nutrition, Physical Activity, and Weight Talk Comparison

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The parent/guardian must have a child between 5th-7th grades at the start of the project;
• The parent must be the custodial parent, living with the child at least 50% of the time (as in the case of joint custody); and
• Parental consent and child assent are obtained.

You may not qualify if:

• Parents of children with self-identified developmental disabilities who would have difficulty understanding the baseline assessment; and
• Parents or families who are not able to speak, read, and understand English or Spanish well enough to complete study procedures.

Sponsors & Collaborators

• Tufts University: lead
• Brown University: collaborator

Study Sites (1)

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 35108294 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Underage Drinking; Adolescent Behavior; Communication

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior; Alcohol Drinking; Drinking Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Margie Skeer
• Organization: Tufts University

margie.skeer@tufts.edu

8579191262

Study Officials

• Margie Skeer, ScD, MPH, MSW

  Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 24, 2019
• Study Start: March 6, 2019
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: July 9, 2025
• Results First Posted: July 9, 2025

Record last verified: 2025-06

Locations

US (1)