Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily)STANDNCT02048579
Increasing Academic Success in Middle School Students With ADHD
A study testing Behavior Therapy + Motivational Interviewing in people with Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily) and Treatment as Usual, run by Florida International University.
Trial summary
Broadly, the purpose of the proposed study is to test the efficacy of a parent-coordinated, parent-teen-teacher collaborative intervention for middle school students with ADHD and academic impairment (STAND; Supporting Teens' Academic Needs Daily). Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily), Treatment as Usual
- What is being tested?
- Behavior Therapy + Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV-TR ADHD Diagnosis; regular education placement in school; academic impairment
Who cannot join
- IQ<80; Autism or PDD diagnosis;
About this study
Broadly, the purpose of the proposed study is to test the efficacy of a parent-coordinated, parent-teen-teacher collaborative intervention for middle school students with ADHD and academic impairment (STAND; Supporting Teens' Academic Needs Daily). [This model was chosen because of its potential ability to promote treatment maintenance and generalizability across school years, because parents will be taught to implement, monitor, and adjust intervention components as needed. Key innovative components in the STAND intervention address previously reported treatment barriers: 1) a parent-delivered academic intervention to promote maintenance and generalization across school years, and to relieve some of the burden of intervention delivery from teachers, 2) motivational interviewing to address parent disengagement from and adolescent resistance to the treatment process, 3) multiple tailored options for home-school communication, including a web-based support system, to facilitate home-school communication, and 4) empowering parents by coaching them to effectively and tactfully involve teachers in the treatment planning and monitoring process in order to increase teachers' willingness to support the child's academic needs. To study the feasibility and preliminary efficacy of the STAND treatment model,] two cohorts of 42 middle school students with ADHD will be recruited (total N=84) and randomly assigned to participate in STAND or a treatment-as-usual monitoring group. All participants will complete intake, mid-treatment, post-treatment, [and follow-up] assessments designed to monitor academic functioning, [intervention feasibility, compliance, and satisfaction].
Aim 1: The proposed study will evaluate the efficacy, [maintenance, and cross-school year generalization] of a parent-teen-teacher collaborative intervention (Supporting Teens' Academic Needs Daily; STAND) vs. treatment as usual to increase the academic functioning of middle school students with ADHD. Intervention effects on ADHD symptomatology and impairment, grade-point-average (GPA), [organization, daily planner use], homework completion, teacher ratings of academic functioning and classroom behavior, and the parent-teen relationship will be examined.
Read more
Aim 2: The proposed study will examine the acceptability and feasibility of the STAND program. Parents and teens will report on [satisfaction, barriers to treatment participation, therapeutic alliance, and treatment credibility] throughout the intervention and follow-up period. [Therapists will also complete ratings of parent and adolescent engagement and compliance with treatment procedures] will be collected from participants in the program. Parent, teen, and teacher compliance with intervention procedures will also be measured in order to assess feasibility. Treatment fidelity measures will also be collected in order to measure clinician adherence to the manualized STAND procedures.
Aim 3: The proposed study will also explore ways to improve home-school communication during the middle school years. To this end, families will be given options regarding the modality of communication with teachers, and parent, teen, and teacher preferences for medium of intervention delivery will be examined (i.e., web-based, email, paper/pencil).
- Conditions
- Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily), Treatment as Usual
- Being tested
- Behavior Therapy + Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Therapy + Motivational InterviewingBehavioural
Also called Supporting Teens' Academic Needs Daily (STAND)
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Not described |
| Behavior Therap + Motivational Interviewing | Experimental | Supporting Teens' Academic Needs Daily Therapy program delivered to parents and teens Receives: Behavioral: Behavior Therapy + Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade Point Average
Measured: One year
Secondary outcomes (2)
Parent Rated Adolescent Academic Problems
Measured: One Year
parent rated ADHD symptoms
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 posted29 Jan 2014 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily)Studies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret H Sibley, Ph.D., Principal investigator, Florida International UniversityWillam Pelham, Ph.D., Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048579
- Sponsor's protocol ID
- R34MH092466-01A1
- Acronym
- STAND
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Academic Success in Middle School Students With ADHD
- ClinicalTrials.gov ID
- NCT02048579
- Acronym / sponsor ID
- STAND / R34MH092466-01A1
- Conditions
- Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily), Treatment as Usual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Broadly, the purpose of the proposed study is to test the efficacy of a parent-coordinated, parent-teen-teacher collaborative intervention for middle school students with ADHD and academic impairment (STAND; Supporting Teens' Academic Needs Daily). [This model was chosen because of its potential ability to promote treatment maintenance and generalizability across school years, because parents will be taught to implement, monitor, and adjust intervention components as needed. Key innovative components in the STAND intervention address previously reported treatment barriers: 1) a parent-delivered academic intervention to promote maintenance and generalization across school years, and to relieve some of the burden of intervention delivery from teachers, 2) motivational interviewing to address parent disengagement from and adolescent resistance to the treatment process, 3) multiple tailored options for home-school communication, including a web-based support system, to facilitate home-school communication, and 4) empowering parents by coaching them to effectively and tactfully involve teachers in the treatment planning and monitoring process in order to increase teachers' willingness to support the child's academic needs. To study the feasibility and preliminary efficacy of the STAND treatment model,] two cohorts of 42 middle school students with ADHD will be recruited (total N=84) and randomly assigned to participate in STAND or a treatment-as-usual monitoring group. All participants will complete intake, mid-treatment, post-treatment, [and follow-up] assessments designed to monitor academic functioning, [intervention feasibility, compliance, and satisfaction].
Aim 1: The proposed study will evaluate the efficacy, [maintenance, and cross-school year generalization] of a parent-teen-teacher collaborative intervention (Supporting Teens' Academic Needs Daily; STAND) vs. treatment as usual to increase the academic functioning of middle school students with ADHD. Intervention effects on ADHD symptomatology and impairment, grade-point-average (GPA), [organization, daily planner use], homework completion, teacher ratings of academic functioning and classroom behavior, and the parent-teen relationship will be examined.
Aim 2: The proposed study will examine the acceptability and feasibility of the STAND program. Parents and teens will report on [satisfaction, barriers to treatment participation, therapeutic alliance, and treatment credibility] throughout the intervention and follow-up period. [Therapists will also complete ratings of parent and adolescent engagement and compliance with treatment procedures] will be collected from participants in the program. Parent, teen, and teacher compliance with intervention procedures will also be measured in order to assess feasibility. Treatment fidelity measures will also be collected in order to measure clinician adherence to the manualized STAND procedures.
Aim 3: The proposed study will also explore ways to improve home-school communication during the middle school years. To this end, families will be given options regarding the modality of communication with teachers, and parent, teen, and teacher preferences for medium of intervention delivery will be examined (i.e., web-based, email, paper/pencil).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | – |
| Behavior Therap + Motivational Interviewing | Experimental | Behavioral: Behavior Therapy + Motivational InterviewingSupporting Teens' Academic Needs Daily Therapy program delivered to parents and teens |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- DSM-IV-TR ADHD Diagnosis; regular education placement in school; academic impairment
Key exclusion criteria (1 listed)
- IQ<80; Autism or PDD diagnosis;
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 |
|---|---|---|
| Behavior Therapy + Motivational InterviewingAlso: Supporting Teens' Academic Needs Daily (STAND) | Behavioural | Behavior Therap + Motivational Interviewing |
Primary outcome
Grade Point Average
Time frame: One year
2 secondary outcomes
Parent Rated Adolescent Academic Problems
Time frame: One Year
parent rated ADHD symptoms
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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.
Margaret H Sibley, Ph.D. principal investigator
Florida International University
Willam Pelham, Ph.D. principal investigator
Florida International University
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Therapy + Motivational Interviewing in people with Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily) and Treatment as Usual, run by Florida International University.
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 1 inclusion and 1 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Grade Point Average (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.