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

August 3, 2015 updated by: The National Center on Addiction and Substance Abuse at Columbia University
The goal of this proposal is to develop and pilot a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD) into behavioral treatment services for adolescent substance users with comorbid ADHD in everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU) that can significantly impede successful ASU treatment but is vastly under-diagnosed and undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and compliance is particularly difficult to achieve in high-risk adolescent populations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this proposal is to develop and pilot a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD) into behavioral treatment services for adolescent substance users with comorbid ADHD in everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU) that can significantly impede successful ASU treatment but is vastly under-diagnosed and undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and compliance is particularly difficult to achieve in high-risk adolescent populations. The proposed R21 study will use an interrupted time series design to test a brief protocol designed to promote integration of evidence-based ADHD pharmacotherapy into routine behavioral services for ASU: Medication Integration Protocol (MIP). MIP is a 5-session family-based protocol delivered during the early portion of ASU treatment that contains three research-based elements: (1) standardized psychiatric assessment and family-focused psychoeducation about adolescent ADHD; (2) an approved ADHD medication regimen (OROS-MPH) with demonstrated efficacy for ASU/ADHD clients; (3) family-based interventions to support medication acceptance (as indicated) and coordination of care between psychiatric and behavioral services. MIP will be integrated into existing family-based services at one partnering clinical site: 20 ASU/ADHD cases will be treated by site family therapists who will be newly trained and monitored in MIP. The partnering clinic provides family therapy as the routine standard of care for outpatient behavioral health and offers on-site child psychiatry services. 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. Exploratory analyses will generate effect sizes for the short-term impact of MIP on the main targets of ADHD medication: ADHD symptoms and executive cognitive functioning. New study products would include a standardized and piloted MIP protocol, clinician training and fidelity monitoring procedures, and an observational fidelity instrument. If validated, MIP could be utilized as a stand-alone intervention in everyday care, or, be combined with existing manualized treatments for ASU in an effort to develop fully integrated treatment models for ASU/ADHD. Also, MIP could be delivered in conjunction with either family-based treatments or individual treatments that can flexibly include caregivers in early sessions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10009
        • Roberto Clemente Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 13-17, (2) 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
  • current suicidality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medication Integration Protocol
Behavioral: Medication integration protocol
MIP is a 5 session protocol. The first session consists of pretreatment assessment activities using measures administered during routine clinical intake. The following sessions, MIP Sessions 1-4, are meant to be delivered sequentially, commencing sometime after session 2 or 3 of treatment, that is, after completion of initial treatment contracting and engagement interventions that will usually be focused on ASU-related referral problems for this population. The proposed pilot work will shed light on the optimal timing for MIP Sessions 1-4.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medication Integration Protocol Feasibility, as assessed by qualitative interviewing of psychiatrist and therapists and also though qualitative interviews administered to teen and caregiver participants
Time Frame: Ongoing; 3-month follow-up
Brief qualitative interviews will be designed and administered to the on-site psychiatrist and family therapists to capture judgments about the viability and acceptability of MIP compared to previous site practices, as well as its perceived short- and long-term safety and effectiveness for ASU/ADHD cases. A parallel qualitative interview will be administered to teens and caregivers at 3-month follow-up. MIP teens will also receive incentives to maintain medication diaries of daily pill intake, using the NIDA CTN method.
Ongoing; 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The National Center on Addiction and Substance Abuse at Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aaron T Hogue, PhD, The Natl Cntr on Addiction and Substance Abuse at Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R21DA031305-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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