CompletedNot Applicable

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

United States402 participantsStarted 2019-03-06

Plain-language 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.

Who can participate

Age range

9 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of Parent-child Conversations on Substances

Timeframe: 3 months (short-term) and 18 months (long-term)

Targeted Parent-child Communication on Substance Use

Timeframe: 3 months (short-term) and 18 months (long-term)

Parent-child Audio-recorded Conversations About Substance Use

Timeframe: 12 months

Quality of Video-recorded Family Mealtime Interactions

Timeframe: 12 months

Child Substance Use Expectancies (Alcohol)

Timeframe: 18 months

Child Substance Use Expectancies (Cigarettes)

Timeframe: 18 months

Child Substance Use Expectancies (Marijuana)

Timeframe: 18 months

Trial details

NCT IDNCT03925220

SponsorTufts University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

Results submitted2025-03-31

View on ClinicalTrials.gov More Substance-Related Disorders trials

Plain-language summary

Who can participate

Age range

9 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Frequency of Parent-child Conversations on Substances

Timeframe: 3 months (short-term) and 18 months (long-term)

Targeted Parent-child Communication on Substance Use

Timeframe: 3 months (short-term) and 18 months (long-term)

Parent-child Audio-recorded Conversations About Substance Use

Timeframe: 12 months

Quality of Video-recorded Family Mealtime Interactions

Timeframe: 12 months

Child Substance Use Expectancies (Alcohol)

Timeframe: 18 months

Child Substance Use Expectancies (Cigarettes)

Timeframe: 18 months

Child Substance Use Expectancies (Marijuana)

Timeframe: 18 months