Ignite Creation Date:
2024-05-06 @ 3:58 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02420990
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2015-03-27
Brief Title:
Integrated Treatment for Adolescents With ADHD
Sponsor:
The National Center on Addiction and Substance Abuse at Columbia University
Organization:
The National Center on Addiction and Substance Abuse at Columbia University
Study Overview
Official Title:
Randomized Comparison of Evidence-Based Protocols for Adolescents With ADHD in Specialty Care Behavioral Only Versus Integrated Behavioral and Medication Interventions
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASALEAP IT2A
Brief Summary:
Attention-DeficitHyperactivity 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 yesno b Substance use comorbidity yesno c RaceEthnicity 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
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 yesno b Substance use comorbidity yesno c RaceEthnicity 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None