Clinical trial NCT01170013: Substance Use Prevention in Teen Psychiatric Patients
Official title: Substance Abuse Prevention for Preadolescents With Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adolescent Substance Use
Keywords: substance use
adolescents
initiation
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. At the same time, parent monitoring of youth behavior tends to decrease during the adolescent years, creating a source of risk for not only the early onset of AOD use but also escalation. Thus, programs are needed in parenting behaviors and family relationships that are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly true of children with psychiatric disorders who are at higher risk for developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of this study is to test the effectiveness of a family-centered intervention to reduce the risk of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been referred for mental health care due to psychiatric symptomatology, will be randomly assigned to receive either an individually tailored family program or standard care. The experimental intervention, which is based on the Family Check-Up model (Dishion \& Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes principles of motivational interviewing to encourage families to change. Follow-up interviews will be conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and other risky behaviors.

Detailed description: The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. At the same time, parent monitoring of youth behavior tends to decrease during the adolescent years, creating a source of risk for not only the early onset of AOD use but also escalation. Thus, programs are needed in parenting behaviors and family relationships that are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly true of children with psychiatric disorders who are at higher risk for developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of this study is to test the effectiveness of a family-centered intervention to reduce the risk of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been referred for mental health care due to psychiatric symptomatology, will be randomly assigned to receive either an individually tailored family program or standard care. The experimental intervention, which is based on the Family Check-Up model (Dishion \& Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes principles of motivational interviewing to encourage families to change. Follow-up interviews will be conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and other risky behaviors.

Eligibility criteria: Inclusion Criteria:

1. the target child is between the ages of 12-14 years old at the start of the project and living at home with at least one parent/guardian
2. the target child must be receiving services at a mental health clinic and must screen in with a t- score of 70 or above on one of the DSM-oriented scales (ADHD, ODD, CD, anxiety problems, and affective problems) on the Child Behavior Checklist (i.e. reach the clinical cut-off)
3. the child must not report prior AOD use, and
4. parental consent and child assent are obtained.

Exclusion Criteria:

1. the target child is actively psychotic, and
2. the family is not able to speak and understand English or Spanish well enough to complete study procedures.

Primary outcomes:
measure: Parental monitoring/communication
timeFrame: 3 months
measure: Parental monitoring/communication
timeFrame: 6 months
Secondary outcomes:
measure: marijuana use
timeFrame: 3 months
measure: marijuana use
timeFrame: 6 months
measure: alcohol use
timeFrame: 3 months
measure: alcohol use
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Anthony Spirito, PhD
role: PRINCIPAL_INVESTIGATOR
References: