Integrated Treatment for Adolescents With ADHD

ADHD Clinical Trial

— CASALEAP IT2A  

Official title:

Randomized Comparison of Evidence-Based Protocols for Adolescents With ADHD in Specialty Care: Behavioral Only Versus Integrated Behavioral and Medication Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420990
• Other study ID #: PCORI-1403-13704
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2022
• Source: The National Center on Addiction and Substance Abuse at Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• ADHD
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Medication Integration Protocol (MIP)

• Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)

Locations

Country	Name	City	State
United States	The National Center on Addiction and Substance Abuse at Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The National Center on Addiction and Substance Abuse at Columbia University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hogue A, Bobek M, Evans SW. Changing Academic Support in the Home for Adolescents with Attention-Deficit/Hyperactivity Disorder: A Family-Based Clinical Protocol for Improving School Performance. Cogn Behav Pract. 2016 Feb;23(1):14-30. doi: 10.1016/j.cbpra.2014.07.002. Epub 2014 Jul 25. — View Citation

Hogue A, Bobek M, Tau GZ, Levin FR. Clinical Strategies for Integrating Medication Interventions Into Behavioral Treatment for Adolescent ADHD: The Medication Integration Protocol. Child Fam Behav Ther. 2014 Oct 1;36(4):280-304. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use).	ADHD Symptoms were assessed using the Mini International Neuropsychiatric Interview (Version 5.0). A count of symptoms (range 0-14) was utilized with higher numbers represent more symptoms.; Delinquency was assessed using the National Youth Survey Self-Report Delinquency Scale (SRD). A count of delinquent acts was utilized (range 0-68) with higher numbers represent more delinquent acts.; Substance Use was captured with the Comprehensive Addiction Severity Index for Adolescents. Total score was utilized (range 0-60) with higher numbers represent greater substance use.; Externalizing and Internalizing Symptoms were measured with the Child Behavior Checklist. Higher scores correspond to more symptoms; scores on each item range from 0 to 2, and the study variable was calculated by summing items within each scale (externalizing scale range = 0 - 62 units on a scale; internalizing scale range = 0-64 units on a scale).	Baseline to One Year
Primary	Change From Baseline in Quality of Life. Improvements in Executive Functioning and School Functioning.	Executive Functioning was measured with two subscales (self-regulation and self-organization) of the Behavior Rating Inventory of Executive Function. Higher scores correspond to greater difficulty with behavior regulation and organization; scores on each item range from 0 to 2, and the study variable was calculated by summing the scores in each scale (23 items per scale; range 0-46 per scale).; School Functioning was measured three ways: Self-report grades which was coded to reflect 1=Mostly As, 2=As and Bs, 3=Mostly Bs, 4=Bs and Cs, 5=Mostly Cs.; Academic Self-Efficacy was measured using four dichotomous items from the Motivated Strategies for Learning Questionnaire, 1 = endorsing self-efficacy, 0 = no self-efficacy (range =0-4).; Homework problems checklist. Higher scores indicate more problems with homework; scores on each item range from 0 to 3; the study variable was calculated by summing the 11 scale items (total score range = 0-33).	Baseline to One Year
Primary	Treatment Attendance.	Treatment Attendance [sum of the total number of individual, family, and group sessions attended] and Medication Management Sessions [total number of sessions attended] were collected from agency records. Medication Use, coded as "1 = on" or "0 = off" medication at each follow-up point, was captured with the Services Assessment for Children and Adolescents	One Year