RecruitingNot Applicable

Primary Connections for Youth and Families

United States2,300 participantsStarted 2024-03-01

Plain-language summary

The goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment to a in primary care settings. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up.

Who can participate

Age range

12 Years – 17 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: * Youth aged 12-17 years with a primary caregiver (i.e., parental figure) also in attendance to primary care appointment * Youth and caregiver are fluent in English or Spanish * Youth and caregiver are capable of using audio-assisted informed consent procedures and independently operating a hand-held tablet device * Youth and caregiver are complete routine site AOD risk screening questions prompted during PC visit intake

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

Change in Assessment of Liability and Exposure to Substance use and Antisocial Behavior (ALEXSA; Ridenour et al., 2009)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Youth Risk Index (ALEXSA; Ridenour et al., 2009)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Brief Problem Monitor (BPM; Achenbach & Rescorla, 2001)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0; Children's Hospital and Health Center, San Diego, CA)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Services Assessment for Children and Adolescents (SACA; Stiffman et al., 2000)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Parent-Teen Alcohol and Other Drug Use Communication Frequency (Koning et al., 2014)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Trial details

NCT IDNCT05964010

SponsorThe National Center on Addiction and Substance Abuse at Columbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11

Contact for this trial

Nicole P Porter, PhD

212-841-5265 nporter@toendaddiction.org

View on ClinicalTrials.gov More Substance Use trials

Plain-language summary

Who can participate

Age range

12 Years – 17 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

Change in Assessment of Liability and Exposure to Substance use and Antisocial Behavior (ALEXSA; Ridenour et al., 2009)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Youth Risk Index (ALEXSA; Ridenour et al., 2009)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Brief Problem Monitor (BPM; Achenbach & Rescorla, 2001)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0; Children's Hospital and Health Center, San Diego, CA)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Services Assessment for Children and Adolescents (SACA; Stiffman et al., 2000)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up

Change in Parent-Teen Alcohol and Other Drug Use Communication Frequency (Koning et al., 2014)

Timeframe: Initial and 3, 6, 9, and 12 months follow-up