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Behavioral Intervention

Integrated Treatment for Substance Use Disorder (CASALEAP IT2A Trial)

N/A
Waitlist Available
Led By Aaron T Hogue, Ph.D.
Research Sponsored by The National Center on Addiction and Substance Abuse at Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary caregiver able to participate in treatment
Adolescent meets DSM-5 diagnostic criteria for ADHD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

CASALEAP IT2A Trial 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.

Eligible Conditions
  • Substance Use Disorder
  • Attention Deficit Hyperactivity Disorder (ADHD)

CASALEAP IT2A Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CASALEAP IT2A Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Quality of Life. Improvements in Executive Functioning and School Functioning.
Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use).
Treatment Attendance.
Secondary outcome measures
Medication Uptake (Type and dose of current prescription and number of days that medication was taken during the assessment period.)

CASALEAP IT2A Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated TreatmentExperimental Treatment2 Interventions
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.
Group II: Behavioral Only- TreatmentActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
2015
N/A
~150
Medication Integration Protocol (MIP)
2015
N/A
~150

Find a Location

Who is running the clinical trial?

The National Center on Addiction and Substance Abuse at Columbia UniversityLead Sponsor
9 Previous Clinical Trials
3,025 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
548 Previous Clinical Trials
29,996,442 Total Patients Enrolled
Aaron T Hogue, Ph.D.Principal InvestigatorDirector of Adolescent and Family Research
1 Previous Clinical Trials
14 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby Mar 2025