ADHDCASALEAP IT2ANCT02420990
Integrated Treatment for Adolescents With ADHD
A study testing Medication Integration Protocol (MIP) and Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) in people with ADHD and Substance Use Disorders, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- ADHD, Substance Use Disorders
- What is being tested?
- Medication Integration Protocol (MIP) and Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The National Center on Addiction and Substance Abuse at Columbia University
New York, New York, 10017
About this study
Official title: Randomized Comparison of Evidence-Based Protocols for Adolescents With ADHD in Specialty Care: Behavioral Only Versus Integrated Behavioral and Medication Interventions
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.
Read more
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.
- Conditions
- ADHD, Substance Use Disorders
- Being tested
- Medication Integration Protocol (MIP), Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
- Keywords
- ADHD, Adolescents, Substance Use Disorders
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Integration Protocol (MIP)Behavioural
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Only- Treatment | Active comparator | 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. Receives: Behavioral: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) |
| Integrated Treatment | Experimental | 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. Receives: Behavioral: Medication Integration Protocol (MIP); Behavioral: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to One Year
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).
Measured: Baseline to One Year
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
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study start1 Mar 2015
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Aaron T Hogue, Ph.D., Principal investigator, Director of Adolescent and Family Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420990
- Sponsor's protocol ID
- PCORI-1403-13704
- Acronym
- CASALEAP IT2A
- Status last verified
- Oct 2022
- First submitted
- 27 Mar 2015
- Last updated
- 14 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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. doi: 10.1080/07317107.2014.967631.
PubMed 25505817Hogue 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.
PubMed 34103882Hogue A, Horan Fisher J, Dauber S, Bobek M, Porter N, Henderson CE, Evans SW. Randomized Trial of Academic Training and Medication Decision-Making for Adolescents with ADHD in Usual Care. J Clin Child Adolesc Psychol. 2021 Nov-Dec;50(6):874-887. doi: 10.1080/15374416.2020.1716362. Epub 2020 Feb 20.
PubMed 32078394
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Evidence-Based Protocols for Adolescents With ADHD in Specialty Care: Behavioral Only Versus Integrated Behavioral and Medication Interventions
- ClinicalTrials.gov ID
- NCT02420990
- Acronym / sponsor ID
- CASALEAP IT2A / PCORI-1403-13704
- Conditions
- ADHD, Substance Use Disorders
- Keywords
- ADHD, Adolescents, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Posted 18 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Only- Treatment | Active comparator | Behavioral: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)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. |
| Integrated Treatment | Experimental | Behavioral: Medication Integration Protocol (MIP), Behavioral: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Integration Protocol (MIP) | Behavioural | Integrated Treatment |
| Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) | Behavioural | Behavioral Only- Treatment, Integrated Treatment |
Primary outcome
Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use).
Time frame: Baseline to One Year
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).
Change From Baseline in Quality of Life. Improvements in Executive Functioning and School Functioning.
Time frame: Baseline to One Year
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).
Treatment Attendance.
Time frame: One Year
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25505817Hogue 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. doi: 10.1080/07317107.2014.967631.
- Background: PubMed 34103882Hogue 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.
- Derived from this study: PubMed 32078394Hogue A, Horan Fisher J, Dauber S, Bobek M, Porter N, Henderson CE, Evans SW. Randomized Trial of Academic Training and Medication Decision-Making for Adolescents with ADHD in Usual Care. J Clin Child Adolesc Psychol. 2021 Nov-Dec;50(6):874-887. doi: 10.1080/15374416.2020.1716362. Epub 2020 Feb 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron T Hogue, Ph.D. principal investigator
Director of Adolescent and Family Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Integration Protocol (MIP) and Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) in people with ADHD and Substance Use Disorders, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use). (time frame: Baseline to One Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420990, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.