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Integrated Treatment for Adolescents With ADHD (CASALEAP IT2A)

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ClinicalTrials.gov Identifier: NCT02420990
Recruitment Status : Recruiting
First Posted : April 20, 2015
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
The National Center on Addiction and Substance Abuse at Columbia University

Brief Summary:

Attention-Deficit/Hyperactivity Disorder (ADHD) exists in 20-50% of the 3 million adolescents annually enrolled in outpatient mental health and substance use treatment. Adolescents with ADHD present deficits in attention, self-regulation, and social competence that significantly impede achievement of developmental and educational milestones. Currently there are only two evidence-based treatment options for this age group: academic training and stimulant medications. Both options remain vastly underutilized. Academic training is not available in most school settings and rarely implemented in clinical care. Similarly, ADHD medications are rarely utilized with adolescents in primary or specialty care for a host of reasons related to stigma, misinformation about effects and side effects, and adolescent autonomy issues. Moreover, the widespread fragmentation of pharmacological versus behavioral services prevents families from making informed treatment selections.

The primary objective of this randomized parametric trial is to compare the effectiveness of behavioral only versus integrated (behavioral plus medication decision-making) interventions for adolescents with ADHD in outpatient behavioral services. The behavioral intervention, Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA), contains three components: ADHD psychoeducation, family-based motivational interventions, and academic training. The medication decision-making intervention, Medication Integration Protocol (MIP), contain three components: psychoeducation about ADHD medication, family decision-making, and medication management. The study will compare the effects of two legitimate treatment options for adolescents with ADHD on service utilization, behavioral symptoms, and quality of life. It will generate new evidence on patient-centered treatment selection that aligns with family-specific principles and treatment goals.

This parametric comparative trial will randomly assign 140 inner-city adolescents with ADHD to (1) CASH-AA Only or (2) CASH-AA + MIP. Treatment will occur in community behavioral health clinics. All participants will receive behavioral interventions (CASH-AA): family psychoeducation in ADHD symptoms, executive functioning, and developmental impacts; family-based motivation and ADHD accommodation interventions; and academic training focused on home environment support and organizational skills. Half of the participants will also receive medication decision-making interventions (MIP): ADHD medication psychoeducation, family decision-making interventions, and (for those who elect to start medication) coordinated medication management. Half of the sample will have comorbid substance use problems. Treatment will occur in three community clinics; therapists will be randomly assigned to study condition. Caregivers and adolescents will complete assessments at baseline, 3, 6, and 12-month follow-up. Multilevel modeling will compare the effectiveness of each condition on key patient and service use outcomes. Patient-centered analyses will explore differential treatment effects based on (a) Medication decision (yes/no); (b) Substance use comorbidity (yes/no); (c) Race/Ethnicity (Hispanic, African American).

Quantitative outcome analyses will test for service use effects, symptom reduction, and quality of life improvements that are primary reasons for seeking clinical services. Qualitative interviews will document family-specific rationale for decisions about medication, compliance with behavioral and medication interventions, and suggestions for improving services and service integration. Note that families assigned to CASH-AA Only will retain the option of pursuing ADHD medication through treatment-as-usual procedures at their respective clinic. Similarly, families assigned to CASH-AA + MIP will not be required to start ADHD medication. Instead, they will receive informed-choice interventions and can choose when and if to start medication; the study will assess the impact of these decisions on clinical outcomes.

If proven efficacious, the CASH-AA and MIP protocols could be rapidly disseminated individually or as an integrated protocol into routine behavioral healthcare settings. The protocols can also be readily combined with other behavioral treatments to form a multicomponent treatment package for adolescents with co-occurring behavior problems. In addition, the family-based, patient-centered CASH-AA and MIP protocols could be delivered in conjunction with other family-based treatments or with individual approaches that flexibly include caregivers in multiple treatment sessions. This makes CASH-AA and MIP highly efficient clinical resources for addressing ADHD-related problems in any outpatient setting that serves adolescents and their families.


Condition or disease Intervention/treatment Phase
ADHD Substance Use Disorders Behavioral: Medication Integration Protocol (MIP) Behavioral: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Evidence-Based Protocols for Adolescents With ADHD in Specialty Care: Behavioral Only Versus Integrated Behavioral and Medication Interventions
Study Start Date : April 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Active Comparator: Behavioral Only- Treatment
All participants will receive behavioral interventions (CASH-AA): family psycho-education in ADHD symptoms, executive functioning, and developmental impacts; family-based motivation and ADHD accommodation interventions; and academic training focused on home environment support and organizational skills.
Behavioral: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
Experimental: Integrated Treatment
Half of the participants will also receive medication decision-making interventions (MIP): ADHD medication psychoeducation, family decision-making interventions, and (for those who elect to start medication) coordinated medication management.
Behavioral: Medication Integration Protocol (MIP)
Behavioral: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)



Primary Outcome Measures :
  1. Behavioral Symptoms: Conduct Problems (Number of times engaged in overt and covert delinquent acts during the assessment period.) [ Time Frame: One Year ]
    Number of times engaged in overt and covert delinquent acts during the assessment period.

  2. Behavioral Symptoms: Substance Use Problems (Number of days used alcohol or illegal drugs per month during the assessment period.) [ Time Frame: One Year ]
  3. Behavioral Symptoms: ADHD Symptoms (Number of ADHD symptoms endorsed.) [ Time Frame: One Year ]
    Number of ADHD symptoms endorsed.


Secondary Outcome Measures :
  1. Medication Uptake (Type and dose of current prescription and number of days that medication was taken during the assessment period.) [ Time Frame: One Year ]
    Type and dose of current prescription and number of days that medication was taken during the assessment period.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary caregiver able to participate in treatment
  • Adolescent meets DSM-5 diagnostic criteria for ADHD
  • Adolescents who are substance users (50% of sample) meet ASAM criteria for non-intensive outpatient services
  • Adolescent not enrolled in any other behavioral treatment
  • Caregiver expresses desire, and adolescent expresses willingness, to participate in outpatient treatment
  • Family has health benefits that meet the requirements of study treatment sites, all of which accept a broad range of insurance plans including Medicaid.

Exclusion Criteria:

  • Intellectual Disability or Autism-Spectrum Disorder
  • Medical/psychiatric illness requiring hospitalization
  • Current psychotic symptoms; active suicidal ideation
  • Severe substance use problems that require immediate relief (detox or residential placement)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420990


Contacts
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Contact: Aaron T Hogue, Ph.D. 2128415278 AHogue@casacolumbia.org

Locations
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United States, New York
The National Center on Addiction and Substance Abuse at Columbia University Recruiting
New York, New York, United States, 10017
Contact: Jacqueline Fisher, Ph.D.    212-841-5242    leap@casacolumbia.org   
Principal Investigator: Aaron T Hogue, Ph.D.         
Sponsors and Collaborators
The National Center on Addiction and Substance Abuse at Columbia University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Aaron T Hogue, Ph.D. Director of Adolescent and Family Research

Publications:
Hogue, A., Bobek, M., & Evans, S. W. (2014). Changing academic support in the home for adolescents with Attention-Deficit/Hyperactivity Disorder: A family-based clinical protocol for improving school performance. Cognitive and Behavioral Practice. http://dx.doi.org/10.1016/j.cbpra.2014.07.002

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Responsible Party: The National Center on Addiction and Substance Abuse at Columbia University
ClinicalTrials.gov Identifier: NCT02420990     History of Changes
Other Study ID Numbers: PCORI-1403-13704
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by The National Center on Addiction and Substance Abuse at Columbia University:
ADHD
Adolescents
Substance Use Disorders

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders