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Family Communication Intervention for Preventing Adolescent Substance Use
N/A
Waitlist Available
Led By Margie Skeer, ScD, MPH, MSW
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The parent/guardian must have a child between 5th-7th grades at the start of the project;
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up short-term (3 and 6 months); long-term (12 and 18 months)
Awards & highlights
Study Summary
This trial is testing a new substance misuse prevention intervention that is based on family communication. The goal is to increase the quality time that parents spend with their children, talking about the harms associated with substance use, in order to prevent the misuse of substances among their children as they enter adolescence.
Who is the study for?
This trial is for parents or guardians with a child in 5th-7th grade, who live with the child at least half the time. They must be able to understand English or Spanish well enough to participate in study procedures and agree to discuss substance use harms during family meals.Check my eligibility
What is being tested?
The study tests a new way of preventing substance misuse by improving parent-child communication. It encourages families to spend quality time together, particularly during meals, where they can talk about the dangers of alcohol and drug use.See study design
What are the potential side effects?
Since this intervention involves educational activities rather than medical treatments, there are no direct physical side effects. However, discussing sensitive topics like substance misuse may cause discomfort or emotional reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is in 5th to 7th grade at the project's start.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ short-term (3 and 6 months); long-term (12 and 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~short-term (3 and 6 months); long-term (12 and 18 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in child affiliation with substance-using peers
Changes in child intentions to use substances
Changes in child substance use expectancies (alcohol)
+7 moreSecondary outcome measures
Changes in pre/early-adolescent substance use initiation
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Substance Use Prevention InterventionExperimental Treatment1 Intervention
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.
Group II: Nutrition, Physical Activity, and Weight Talk ComparisonActive Control1 Intervention
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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Who is running the clinical trial?
Brown UniversityOTHER
456 Previous Clinical Trials
562,081 Total Patients Enrolled
Tufts UniversityLead Sponsor
263 Previous Clinical Trials
660,774 Total Patients Enrolled
Margie Skeer, ScD, MPH, MSWPrincipal Investigator - Tufts University School of Medicine
Tufts University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am the custodial parent and live with my child at least half the time.My child has a developmental disability that makes understanding assessments hard.My child is in 5th to 7th grade at the project's start.
Research Study Groups:
This trial has the following groups:- Group 1: Substance Use Prevention Intervention
- Group 2: Nutrition, Physical Activity, and Weight Talk Comparison
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 45 or older eligible to volunteer in this trial?
"This trial is only open to those between the ages of 9 and 14. There are 83 other clinical trials available for children below 18 years old, while there are 269 studies that cater to adults over 65."
Answered by AI
Are there still opportunities for participation in this clinical study?
"Indeed, per the data hosted on clinicaltrials.gov, this medical experiment is actively recruiting participants. It was initially posted in March of 2019 and has been recently updated in May 2022; the trial requires 1000 patients to be recruited from 1 specified site."
Answered by AI
Does my profile meet the qualifications for this research trial?
"For individuals to be eligible for this trial, they must have a documented history of drug abuse and be within the age range 9-14. Approximately 1000 patients are being recruited at present."
Answered by AI
What is the capacity for this research project?
"Affirmative. Information found on clinicaltrials.gov denotes that the recruitment for this clinical trial, which began publication on March 6th 2019, is ongoing and currently seeking 1000 participants from a single site."
Answered by AI
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