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

Study Overview
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Brief Summary
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder

Intervention / Treatment
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* Behavioral: MIP Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Counseling with MIP Protocol<br>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. | Behavioral: MIP Protocol<br>* 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.<br>|
| No Intervention: Historical Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini International Neuropsychiatric Interview (MINI) Version 5.0 | MINI 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. | Follow-up in 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior Rating Inventory of Executive Function (BRIEF) | The 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. | Follow-up at 3-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comorbid, ADHD, SUD, ASU