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Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder

Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01369459
Acronym
MIP
Enrollment
14
Registered
2011-06-09
Start date
2011-11-30
Completion date
2014-12-31
Last updated
2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder

Keywords

Comorbid, ADHD, SUD, ASU

Brief summary

The goal of this project is to develop and test a brief protocol designed to systematically integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) into behavioral treatment services for adolescent substance users with co-morbid ADHD in everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services utilization, medication acceptance and compliance, and satisfaction with treatment services.

Interventions

BEHAVIORALMIP Protocol

We intend for MIP to be a 5-session, family-based protocol delivered during the early portion of ASU treatment. MIP will contain three elements deemed essential for integrating pharmacological interventions into outpatient behavioral treatment for youth: (1) standardized psychiatric assessment and family-focused psychoeducation about the target problem; (2) an approved medication regimen with demonstrated efficacy for comorbid populations; (3) family-based interventions for medication acceptance and coordination of psychiatric and behavioral services. MIP will incorporate research-proven interventions from each of these core areas.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
The National Center on Addiction and Substance Abuse at Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 13-17 years * Caregiver able to participate in treatment * One day of alcohol use to intoxication or illegal drug use in the past 30 days (or 30 days prior to living in a controlled environment) * endorsement of one or more DSM-IV symptoms of Substance Use or Alcohol Dependence/Abuse * meet ASAM criteria for outpatient substance use treatment * meet DSM-IV criteria for ADHD (with or without onset prior to age 7) * not enrolled in any behavioral treatment

Exclusion criteria

* MDD * Bipolar Disorder * Mental Retardation * PDD * medical or psychiatric illness requiring hospitalization * current psychotic features * currently suicidal

Design outcomes

Primary

MeasureTime frameDescription
Mini International Neuropsychiatric Interview (MINI) Version 5.0Follow-up in 3 monthsMINI is a structured diagnostic interview that assesses DSM-IV diagnoses in adolescents and is designed for administration by lay interviewers. Adolescents and caregivers will complete the Inattentive and Hyperactive/Impulsive scales.

Secondary

MeasureTime frameDescription
Behavior Rating Inventory of Executive Function (BRIEF)Follow-up at 3-monthsThe BRIEF is a parent-report measure of behavioral problems linked to executive functioning and commonly observed in ADHD youth. The BRIEF has been validated on ADHD outpatient samples and teens with mixed clinical diagnoses. This study will use 4 scales: Inhibition, Behavioral Shift, Emotional Control, Plan/Organize.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026