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

Not Applicable

Completed

Conditions: Substance-Related Disorders
Underage Drinking
Drug Use

Registration Number: NCT03925220

Lead Sponsor: Tufts University

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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 402

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Child Substance Use Expectancies (Alcohol)	18 months	Positive and negative expectancies about the affective, cognitive, and behavioral effects of alcohol use will be assessed with the Alcohol Expectancy Questionnaire-Adolescent Form, short version. The tool is comprised of 27 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. Questions 6, 9, 17, and 26 are scored in opposite direction before they are included in the negative sub-scale (remaining items are included in the positive sub-scale). Sub-scales are created by averaging the items and range from 1 to 6. A higher score on the positive expectancies 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.
Child Substance Use Expectancies (Cigarettes)	18 months	Positive and negative expectancies about the affective, cognitive, and behavioral effects of cigarette use will be assessed with the Positive and Negative Outcome Expectancies of Smoking scale. The tool comprises 12 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. The tool has two subscales (positive expectancies, determined by 7 questions; negative expectancies, determined by 5 questions). Summary scores for both the positive and negative expectancies are created. Summary score values range from 0-7 for positive, 0-5 for negative expectancies. Higher 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.
Child Substance Use Expectancies (Marijuana)	18 months	Positive and negative expectancies about the affective, cognitive, and behavioral effects of marijuana use will be assessed with an adapted version of the Marijuana Effect Expectancies Questionnaire - Brief. The tool comprises three standalone subscales (Relaxation/Tension Reduction, Cognitive/Behavioral Impairment, Global Negative Effects) for a total of 27 items. Each item has responses ranging from (1) Strongly Disagree to (6) Strongly Agree. Scores for each subscale are calculated by averaging item scores within that subscale. Each subscale score range is from 1 - 6. Higher scores on each 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.
Child Affiliation With Substance-using Peers	18 months	Using an item from the Monitoring the Future study, children will be asked how many of their friends they think use substances. The item is repeated for each substance. This measure was reported by children only.
Child Willingness to Use Substances	18 months	Child willingness to use substances will be assessed through three items adapted from the measure combining intention and willingness originally developed for tobacco and amphetamines found in Gibbons et al. (1998) Reasoned Action and Social Reaction: Willingness and Intention as Independent Predictors of Health Risk. The three items will be asked for each substance. Each item has response options ranging from (1) Not at all likely to (6) Very likely. Response options are transformed to binary format such that 0 represents (1) Not at all likely and 1 represents (2) Unlikely to (6) Very Likely. 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.
Child Intentions to Use Substances	18 months	One item from the Youth Alcohol and Drug Survey will assess child's intention to use substances in the next 30 days. The question is asked for each substance and has the response options 'No', 'Probably No', 'Probably Yes', 'Yes'. Response options are dichotomized to (1) No \[which includes 'No' and 'Probably No'\] and (2) Yes \[which includes 'Probably Yes' and 'Yes'\]. This measure was reported by children only.
Frequency of Parent-child Conversations on Substances	3 months (short-term) and 18 months (long-term)	Frequency of conversations was measured using an item adapted from a measure for parent-child communication about sex (Miller et al, 1998). Question: "During the past 3-months, how many times have you and your child talked about \[substance\]?" The same question assessed frequency for each substance of interest (alcohol, cigarettes, e-cigarettes, cannabis, other drugs) on a five-point Likert scale from "None" to "A lot". Responses were dichotomized as "Several" or "A lot" versus "None", "Once", or "A few times". This measure was reported by parents and children.
Targeted Parent-child Communication on Substance Use	3 months (short-term) and 18 months (long-term)	An adapted version of the Targeted Parent-Child Communication about Alcohol Scale (Miller-Day et al, 2010) was used to assess targeted communication about alcohol and other drugs use. The ten-item assesses parents' agreement on having communication about substance use related topics and applying strategies parents may have discussed with their child. Items were assessed on a six-point Likert scale from "Strongly agree" to "Strongly disagree". Responses were dichotomized as "Agree" or "Strongly Agree" versus "Strongly Disagree" to "Somewhat Agree". This measure was reported by parents and children.
Parent-child Audio-recorded Conversations About Substance Use	12 months	The prompts, modeled after the Family Assessment Task (FAsTask) where parents and adolescents have a conversation about substance use and related behaviors, were developed by the study team (Spirito et al, 2011). The same prompts are used at each time point. The sub-scales (expectations, messaging, communication style, and strategies) range from 1 to 9 (higher values represent a higher quality conversation compared to lower values). The overall combined score ranges from 4 to 36 (higher values represent a higher quality conversation compared to lower values).
Quality of Video-recorded Family Mealtime Interactions	12 months	The mean quality of mealtime interactions is measured using various scales from the Iowa Family Interaction Rating Scales (IFIRS) coding system: Dyadic Interaction Scales, Dyadic Relationship Scales, Group Interactions Scales, and Parenting Scales. Observed behaviors from 3 video-recorded family meals are assessed and scored on a 9-point scale. A higher score indicates coders observed a higher intensity and/or frequency of the construct in the video-recorded family meals. Each IFIRS scale is scored individually, and the average across the 3 family meals is reported. The items were organized into four subscales: Communication (range: 4-36), Parenting Style (range: 5-45), Dyad Relationship (range: 5-45), and Group Enjoyment (range: 1-9).

Secondary Outcome Measures

Name	Time	Method
Pre/Early-adolescent Substance Use Initiation	18 months	Substance use initiation for each substance will be assessed with three items from the Drug Use Questionnaire. The items will be asked for each substance. Child responds Yes/No to the "have you ever used \[substance\]?" question. This measure was reported by children only.

Trial Locations

Locations (1): Tufts University School of Medicine
🇺🇸
Boston, Massachusetts, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States