What side effects are associated with this type of intervention?

Common treatments for Substance Use Disorders (SUDs) such as cognitive-behavioral therapy (CBT), behavioral couples therapy (BCT), and family-based interventions generally have minimal physical side effects since they are psychosocial in nature. However, patients may experience emotional discomfort as they confront and discuss challenging issues related to substance use. Additionally, there can be initial resistance or increased family tension as dynamics shift and new communication patterns are established. Overall, these therapies are considered safe and are aimed at improving long-term behavioral outcomes and family relationships.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Substance Use Disorders (SUDs), including methadone, buprenorphine, and naltrexone for opioid use disorder, and acamprosate, disulfiram, and naltrexone for alcohol use disorder. While these medications are crucial for managing SUDs, family communication-based interventions, such as the one being studied to enhance parent-child communication and quality time, play a significant role in prevention. These interventions aim to reduce the risk of substance misuse by fostering strong family bonds and open communication, which are essential components in the holistic approach to preventing and treating SUDs.

What other types of research exist?

Promising, novel alternatives to Family Communication-Based Intervention for substance use disorder patients include: 1) Video-delivered family therapeutic interventions, such as the Resilience Enhancement Skills Training (REST), which have shown high feasibility and acceptability for perinatal women with depressive symptoms and family conflict. 2) Text messaging-based relapse prevention programs, like Texting 4 Relapse Prevention (T4RP), which have demonstrated high patient acceptability and support in individuals with schizophrenia or schizoaffective disorder. 3) Mobile phone text messaging and app-based interventions for smoking cessation, which have been effective in increasing abstinence rates. 4) Proactive telephone counseling, which has shown higher quit rates in smoking cessation and could be adapted for substance use disorders. 5) Twelve-step facilitation programs, which have been effective in increasing participation and improving substance use outcomes in various clinical trials.

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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

Summary

This trial tests a program that helps parents talk to their kids about drugs and alcohol during family meals. It targets parents of kids in grades 5-7. The program includes a session, regular calls, and text message tips to improve family communication and prevent substance use.

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.

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.

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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and short-term (3 and 6 months); long-term (12 and 18 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in child affiliation with substance-using peers

Changes in child intentions to use substances

Changes in child substance use expectancies (alcohol)

+7 more

Secondary study objectives

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Substance Use Disorders (SUDs) include Cognitive-Behavioral Therapy (CBT), which helps patients modify harmful thoughts and behaviors related to substance use; Motivational Interviewing (MI), which enhances intrinsic motivation to change by resolving ambivalence; and 12-Step Facilitation, which encourages participation in mutual help groups like Alcoholics Anonymous. Family-based interventions, such as Behavioral Family Counseling, leverage family dynamics to support abstinence and improve social well-being. These mechanisms are crucial for SUD patients as they address both individual and relational factors that contribute to substance use, thereby providing a comprehensive approach to treatment. Enhancing parent-child communication and quality time, as seen in family communication-based interventions, can prevent substance misuse by fostering a supportive environment and addressing early risk factors.

Curative factors in alcohol and drug treatment: behavioral and disease model perspectives.Psychosocial Interventions to Improve Psychological, Social and Physical Wellbeing in Family Members Affected by an Adult Relative's Substance Use: A Systematic Search and Review of the Evidence.On treatment mechanisms--what can we learn from the COMBINE study?