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

Substance-Related Disorders Clinical Trial

Official title:

Testing a Brief Substance Misuse Preventative Intervention for Parents of Youth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03925220
• Other study ID #: 1R01DA045073-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Drug Use
• Substance-Related Disorders
• Underage Drinking

Intervention

Behavioral:
• The SUPPER Project
Substance Use Promoted by Eating family meals Regularly
• Improving nutrition and physical activity among youth
A brief intervention focused on improving nutrition and physical activity among youth

Locations

Country	Name	City	State
United States	Tufts University School of Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in frequency of parent-child conversations about substance use	Frequency of parent-child conversations about substance use will be measured at each timepoint using questions adapted from a measure assessing parent-child conversations about sex in Miller et al. (1998) "Family communication about sex: What are parents saying and are their adolescents listening?"	Short-term (3 and 6 months); long-term (12 and 18 months)
Primary	Changes in quality of parent-child conversations about substance use	Quality of parent-child conversations about substance use will be assessed by an audio-recording of a prompted parent-child conversation using an adapted version of the Family Assessment Task (FAsTask), which will be coded quantitatively.	Short-term (6 months); long-term (12 months)
Primary	Changes in parent-child conversations about substance use	Parent-child communication about substances will be measured with an adapted version of the Targeted Parent-Child Communication about Alcohol Scale. Several dimensions are assessed including parental warnings about the dangers of drugs, advice for how to address drug situations such as offers or peer pressure, and articulation of rules and sanctions around drugs. Ten items are asked of the parent and child at each time point. Items are assessed on a six-point Likert scale from "Strongly agree" to "Strongly disagree".	Short-term (3 and 6 months); long-term (12 and 18 months)
Primary	Changes in quality of family mealtime interactions	The mean quality of mealtime interactions will be 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 will be 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 will be reported.	Short-term (6 months); long-term (12 months)
Primary	Changes in 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, 26 are scored in opposite direction before they are included in the scales. Scores are summed to create a total scale range from 27 - 162. A higher score on the scale indicates a greater belief that alcohol has desirable effects.	18 months
Primary	Changes in 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.	18 months
Primary	Changes in 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 of Relaxation/Tension Reduction, Cognitive/Behavioral Impairment, and Global Negative Effects associated with marijuana use.	18 months
Primary	Changes in 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.	18 months
Primary	Changes in 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. The second two items are reverse coded and the three items are averaged to create a behavioral willingness index that ranges from 1 to 6. Each substance is scored separately. A higher score indicates that the child is more willing to try the substance.	18 months
Primary	Changes in child intentions to use substances	Two items from the Youth Alcohol and Drug Survey will assess child's intention to use substances. The two items will be asked for each substance at baseline and each follow up timepoint. Each item has the response options (0) No, (1) Probably No, (2) Probably Yes, (3) Yes. Each item assessed individually, and each substance is scored separately. A higher score indicates greater intention to use the substance.	18 months
Secondary	Changes in 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 at baseline and each follow up timepoint, and are used to calculate time of initiation and incidence. Child responds Yes/No to the "ever used" question and if responds yes, provides day of first use. Frequency of use question has responses: (0) Never, (1) Once a month or less, (2) About once a week, (3) Several times a week, (4) About once a day, (5) Several times a day.	18 months