Attention Deficit Hyperactivity DisorderNCT04480346
Multisite Study of High School-based Treatment for Adolescents With ADHD
A study testing Challenging Horizons Program in people with Attention Deficit Hyperactivity Disorder, run by Ohio University at 2 sites in United States.
Trial summary
We evaluated the extent to which receiving the school-based multi-component treatment of the Challenging Horizons Program (CHP) would lead to significant improvements in levels of symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic functioning for high school aged adolescents diagnosed… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Challenging Horizons Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2015to 30 Jun 2019
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- On phone screen with parent report a previous diagnosis of ADHD or elevated levels on at least 4 of 9 ADHD symptoms of inattention
- Meet diagnostic criteria for ADHD on structured diagnostic interview with parents or parent and teacher ratings of symptoms and impairment
- Demonstrate an IQ of 75 or greater on the Wechsler Abbreviated Scale of Intelligence - Second Edition
- Attend a participating high school
Who cannot join
- Does not exceed critical threshold on adolescent self report of substance us on the Substance Abuse Subtle Screening Inventory
- Does not meet diagnostic criteria for bipolar disorder, psychosis, or obsessive-compulsive disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio University
Athens, Ohio, 45701
Lehigh University
Bethlehem, Pennsylvania, 18015
About this study
Official title: Multisite Study of School-based Treatment Approaches for Adolescents With ADHD
We evaluated the extent to which receiving the school-based multi-component treatment of the Challenging Horizons Program (CHP) would lead to significant improvements in levels of symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic functioning for high school aged adolescents diagnosed with ADHD. We intended to recruit 200 high school aged adolescents with a diagnosis of ADHD who would be randomly assigned to either CHP or a Community Care condition within each of 12 participating high schools. Outcome measures included parent, teacher and adolescent reports as well as observational data. Measures were collected at initial evaluations which preceded the one academic year of treatment, during the treatment period, and at six-months after treatment ended. Based on previous research with this treatment in middle and high schools, we anticipated meaningful gains for those in the treatment condition at post-treatment and larger gains on some variables at the 6-month follow-up evaluation.
Read the detailed description
We evaluated the extent to which receiving the school-based multi-component treatment of the Challenging Horizons Program (CHP) would lead to significant improvements in levels of symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic functioning for high school aged adolescents diagnosed with ADHD. We intended to recruit 200 high school aged adolescents with a diagnosis of ADHD who would be randomly assigned to either CHP or a Community Care condition within each of 12 participating high schools. Outcome measures included parent, teacher and adolescent reports as well as observational data. Measures were collected at initial evaluations which preceded the one academic year of treatment, during the treatment period, and at six-months after treatment ended. Based on previous research with this treatment in middle and high schools, we anticipated meaningful gains for those in the treatment condition at post-treatment and larger gains on some variables at the 6-month follow-up evaluation. Eligible participants were stratified for medication status and sex following the completion of all eligibility assessments for each of 3 cohorts and were randomly assigned (within schools) to either the CHP or CC condition. Siblings were assigned together such that they would be in the same condition. All measures (except the achievement test which was given at eligibility and post-treatment assessment points) were administered on at least three occasions including pre-treatment (i.e., eligibility or baseline), post-treatment, and 6-month follow-up. Rating scales were completed online using REDCap (Harris et al., 2009) with the exception of the School Functioning Scale.
Participants randomized to the treatment group met with their coaches individually for approximately 15-20 minutes twice per week throughout the academic year, typically during lunch, study hall, or an elective class. Individual sessions included study skills, organization, problem solving, and interpersonal skills training. Ten, 90-minute group sessions were offered to adolescents and parents in the evenings and ran concurrently. The organization intervention occurred during each individual session. During initial sessions, students and coaches worked collaboratively to develop a system of organizing the student's binders or folders and tracking assignments in a daily planner or electronic calendar. Subsequent sessions included a binder and daily planner check in which the student's adherence to the system was recorded and then the student practiced addressing disorganization (e.g., put assignments in the correct folders, update planner). After meeting objective criteria for organization (e.g., at least 80% planner completion for two consecutive weeks), adolescents independently completed organization and planner checks under supervision by coaches.
Each month, coaches checked with students and school records regarding six areas of risk including tardiness, absenteeism, in-school disciplinary actions, out-of-school suspension, failing classes, and missing assignments. If students met a predetermined threshold for risk (e.g., 80% or fewer assignments turned in on time), then the student and coach had a problem-solving discussion. The goal was to both develop a solution to the relevant problem as well as teach students how to use problem-solving skills. The process included (1) defining the problem, (2) setting a goal, (3) brainstorming ways to achieve that goal, (4) selecting one or more of these solutions, (5) determining how to know if the plan is working, (6) setting a date to start implementation, and (7) setting a date to review the success of the plan. During a subsequent session, the coach and student reviewed the results of the plan relative to stated goals and determined if they should continue the plan or make changes. During individual sessions, students and coaches critically reviewed social events and the student's behavior in relation to goals. This was an extension of the evening sessions focused on ISG and involved applying the skills learned in the group meetings to individual social events in the participants' daily lives. For students who were not performing well on tests and quizzes, coaches provided study skills intervention. Coaches reviewed test-taking strategies regarding different styles of test questions (e.g., planning an outline for an essay question). Students were tested on these strategies to demonstrate mastery and then practice the skills on practice tests. Students also learned strategies for using flashcards and class notes effectively to prepare for tests. In the ten evening sessions offered for students the adolescents participated in an interpersonal skills group (ISG) to improve social skills. During the first group, students were introduced to the concepts of ideal self - how they want to be seen, and real self - how they really are seen. Students developed ideal self goals and practiced behaving in ways that aligned with these goals during games and activities and frequently reviewed progess with staff. Parents were offered 10 evening sessions concurrent with students' ISG. Program staff provided psychoeducation about ADHD and common difficulties faced by teenagers, including sleep hygiene. Parents also worked with project staff to develop a homework management plan that determined when students would complete homework each night and for how long.
Participants who were randomized to the CC condition were given a list of available resources in their community and received no services from research staff. Participants in both CC and the treatment condition were informed that they could receive any community services during the duration of the trial.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Challenging Horizons Program
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Challenging Horizons ProgramBehavioural
Intervention delivered in high schools provided by school mental health professional over the course of an academic year with twice-weekly meetings with students and 10 evening group meetings with students and 10 group sessions with parents.
| Study group | Role | What they receive |
|---|---|---|
| CHP treatment | Experimental | Participants assigned to this arm received the treatment described in another section. Receives: Behavioral: Challenging Horizons Program |
| Community Care | No intervention | Participants randomly assigned to this condition received information about service providers in the community, but no services from the investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms
Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.
Measured: Change from Baseline ADHD symptoms through study completion, an average of 9 months.
ADHD symptoms
Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.
Measured: Change from Baseline ADHD symptoms through six months post treatment, an average of 15 months.
Social Skills
Parent ratings on Social Skills Improvement System Rating Scale - parent rating version;There are 46 items on the social skills factor that are rated from 0 to 3 (range 0 to 138) with higher scores indicating better social skills. Scores are converted to age and sex based standard scores (M=100).
Measured: Change from Baseline social skills through study completion, an average of 9 months.
Social Skills
Parent ratings on Social Skills Improvement System Rating Scale - parent rating version;There are 46 items on the social skills factor that are rated from 0 to 3 (range 0 to 138) with higher scores indicating better social skills. Scores are converted to age and sex based standard scores (M=100).
Measured: Change from Baseline social skills through six months post treatment, an average of 15 months.
Grade Point Average
Average of grades assigned by school each grading period;Average calculated based on a 0 to 4 scale with higher GPA corresponding to higher grades.
Measured: Change from Baseline grade point average through study completion, an average of 9 months
Grade Point Average
Average of grades assigned by school each grading period;Average calculated based on a 0 to 4 scale with higher GPA corresponding to higher grades.
Measured: Change from Baseline grade point average through six months post treatment, an average of 15 months.
Organization Skills
Parent ratings on the Children's Organization Skills Scale;This is a 66-item rating scale with three subscales including Task Planning (raw scores range from 6 to 24), Organizing Actions (raw scores range from 10 to 40), and Memory and Materials Management (raw scores range from 10 to 40). High scores indicate worse organization skills.
Measured: Change from Baseline organization skills through study completion, an average of 9 months.
Organization Skills
Parent ratings on the Children's Organization Skills Scale;This is a 66-item rating scale with three subscales including Task Planning (raw scores range from 6 to 24), Organizing Actions (raw scores range from 10 to 40), and Memory and Materials Management (raw scores range from 10 to 40). High scores indicate worse organization skills.
Measured: Change from Baseline organization skills through six months post treatment, an average of 15 months.
Homework Completion
Parent ratings on the Homework Problems Checklist;This is a 20 item scale with scores ranging from 0 to 60 and high scores indicate greater problems completing homework.
Measured: Change from Baseline Homework Completion through study completion, an average of 9 months.
Homework Completion
Parent ratings on the Homework Problems Checklist;This is a 20 item scale with scores ranging from 0 to 60 and high scores indicate greater problems completing homework.
Measured: Change from Baseline Homework Completion through six months post treatment, an average of 15 months.
Classroom Behavior and Academic Performance
Teacher ratings on the School Functioning Scale;This is a 9-item scale designed to measure behavior and academic performance in secondary school classrooms with scores ranging from 9 to 47. One 4-item factor focuses on classroom engagement behaviors and performance on tests and quizzes and scores range from 4 to 20 with high scores indicating better performance. Three questions about disruptive behavior have a range of scores from 3 to 15 with high scores indicating more disruption. Two questions focusing on interpersonal relationships produce scores ranging from 2 to 12 with high scores indicating better relationships.
Measured: Change from Baseline classroom behavior and academic performance through study completion, an average of 9 months.
Classroom Behavior and Academic Performance
Teacher ratings on the School Functioning Scale;This is a 9-item scale designed to measure behavior and academic performance in secondary school classrooms with scores ranging from 9 to 47. One 4-item factor focuses on classroom engagement behaviors and performance on tests and quizzes and scores range from 4 to 20 with high scores indicating better performance. Three questions about disruptive behavior have a range of scores from 3 to 15 with high scores indicating more disruption. Two questions focusing on interpersonal relationships produce scores ranging from 2 to 12 with high scores indicating better relationships.
Measured: Change from Baseline classroom behavior and academic performance through six months post treatment, an average of 15 months.
Secondary outcomes (16)
Emotion Regulation
Student ratings on the Difficulties with Emotion Regulation Scale;This is a 36-item scale with scores ranging from 0 to 180 and high scores representing more dysregulation of emotion.
Measured: Change from Baseline emotion regulation through study completion, an average of 9 months.
Emotion Regulation
Student ratings on the Difficulties with Emotion Regulation Scale;This is a 36-item scale with scores ranging from 0 to 180 and high scores representing more dysregulation of emotion.
Measured: Change from Baseline emotion regulation through six months post treatment, an average of 15 months.
Anxiety
Student ratings on the Beck Youth Inventory II;This is a 20-item scale ranging from 0 to 80 with high scores representing more anxiety.
Measured: Change from Baseline anxiety through study completion, an average of 9 months.
Anxiety
Student ratings on the Beck Youth Inventory II;This is a 20-item scale ranging from 0 to 80 with high scores representing more anxiety.
Measured: Change from Baseline anxiety through six months post treatment, an average of 15 months.
Depression
Student ratings on the Reynold's Adolescent Depression Scale 2 - Short Form:This is a 10-item measure with item scores ranging from 1 to 4 (total range 10 to 40) and higher scores indicate greater depression.
Measured: Change from Baseline depression through study completion, an average of 9 months.
Depression
Student ratings on the Reynold's Adolescent Depression Scale 2 - Short Form;This is a 10-item measure with item scores ranging from 1 to 4 (total range 10 to 40) and higher scores indicate greater depression.
Measured: Change from Baseline depression through six months post treatment, an average of 15 months.
School Performance
Parent ratings on the Adolescent Academic Problems Checklist;This is a 24-item checklist with scores ranging from 0 to 72 and high scores indicating greater problems.
Measured: Change from Baseline school performance through study completion, an average of 9 months.
School Performance
Parent ratings on the Adolescent Academic Problems Checklist;This is a 24-item checklist with scores ranging from 0 to 72 and high scores indicating greater problems.
Measured: Change from Baseline school performance through six months post treatment, an average of 15 months.
Symptoms of conduct disorder and oppositional defiant disorder
Parent ratings on the Disruptive Behavior Disorders checklist;This is a 23-item scale with scores ranging from 0 to 69 with high scores indicating a higher level of symptoms.
Measured: Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through study completion, an average of 9 months.
Symptoms of conduct disorder and oppositional defiant disorder
Parent ratings on the Disruptive Behavior Disorders checklist;This is a 23-item scale with scores ranging from 0 to 69 with high scores indicating a higher level of symptoms.
Measured: Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through six months post treatment, an average of 15 months.
Family relationships
Parent ratings on the Index of Family Relations;This is a 25-item scale with scores ranging from 0 to 150 with high scores indicating greater family distress in relationships.
Measured: Change from Baseline family relationships through study completion, an average of 9 months.
Family relationships
Parent ratings on the Index of Family Relations;This is a 25-item scale with scores ranging from 0 to 150 with high scores indicating greater family distress in relationships.
Measured: Change from Baseline family relationships through six months post treatment, an average of 15 months.
Parent stress
Parent ratings on the Stress Index for Parents of Adolescents;This is a 112-item scale and we used the 40-item Adolescent Domain subscale and the 32-item Adolescent-Parent Relationship Domain scale. Scores on the Adolescent Domain subscale ranged from 40 to 200 and scores on the Adolescent-Parent Relationship Domain scale ranged from 32 to 160 with high scores on each scale reflecting greater parent stress.
Measured: Change from Baseline parent stress through study completion, an average of 9 months
Parent stress
Parent ratings on the Stress Index for Parents of Adolescents;This is a 112-item scale and we used the 40-item Adolescent Domain subscale and the 32-item Adolescent-Parent Relationship Domain scale. Scores on the Adolescent Domain subscale ranged from 40 to 200 and scores on the Adolescent-Parent Relationship Domain scale ranged from 32 to 160 with high scores on each scale reflecting greater parent stress.
Measured: Change from Baseline parent stress through six months post treatment, an average of 15 months.
Academic Achievement
Adolescent's performance on the Woodcock Johnson Tests of Achievement;This is a comprehensive performance measure of achievement with standard scores with a mean of 100 and higher scores indicating higher levels of achievement.
Measured: Change from Baseline academic achievement through study completion, an average of 9 months.
Academic Achievement
Adolescent's performance on the Woodcock Johnson Tests of Achievement;This is a comprehensive performance measure of achievement with standard scores with a mean of 100 and higher scores indicating higher levels of achievement.
Measured: Change from Baseline academic achievement through six months post treatment, an average of 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Mar 2015
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Lehigh University
- Responsible party
- Principal investigator, Steven Evans, Ohio University
- Investigators
- Steven W Evans, Ph.D., Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480346
- Sponsor's protocol ID
- R305A140356 - 15
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available after the main outcome studies are published. The Co-PIs will consider requests in relation to potential overlap with investigator team planned manuscripts and qualifications of person making the request.
Publications
Dawson AE, Wymbs BT, Evans SW, DuPaul GJ. Exploring how adolescents with ADHD use and interact with technology. J Adolesc. 2019 Feb;71:119-137. doi: 10.1016/j.adolescence.2019.01.004. Epub 2019 Jan 25.
PubMed 30690333DuPaul GJ, Evans SW, Allan D, Puzino K, Xiang J, Cooper J, Owens JS. High school teacher ratings of academic, social, and behavioral difficulties: Factor structure and normative data for the School Functioning Scale. Sch Psychol. 2019 Sep;34(5):479-491. doi: 10.1037/spq0000323. Epub 2019 May 2.
PubMed 31045408Bunford N, Dawson AE, Evans SW, Ray AR, Langberg JM, Owens JS, DuPaul GJ, Allan DM. The Difficulties in Emotion Regulation Scale-Parent Report: A Psychometric Investigation Examining Adolescents With and Without ADHD. Assessment. 2020 Jul;27(5):921-940. doi: 10.1177/1073191118792307. Epub 2018 Aug 16.
PubMed 30112924Margherio SM, Capps ER, Monopoli JW, Evans SW, Hernandez-Rodriguez M, Owens JS, DuPaul GJ. Romantic Relationships and Sexual Behavior Among Adolescents With ADHD. J Atten Disord. 2021 Aug;25(10):1466-1478. doi: 10.1177/1087054720914371. Epub 2020 Apr 24.
PubMed 32329399Margherio SM, Brickner MA, Evans SW, Sarno Owens J, DuPaul GJ, Allan NP. The role of emotion regulation in alcohol use among adolescents with attention-deficit/hyperactivity disorder. Psychol Addict Behav. 2020 Nov;34(7):772-782. doi: 10.1037/adb0000582. Epub 2020 Apr 9.
PubMed 32271054Monopoli WJ, Evans SW, Benson K, Allan NP, Owens JS, DuPaul GJ, Bunford N. Assessment of a conceptually informed measure of emotion dysregulation: Evidence of construct validity vis a vis impulsivity and internalizing symptoms in adolescents with ADHD. Int J Methods Psychiatr Res. 2020 Dec;29(4):1-14. doi: 10.1002/mpr.1826. Epub 2020 Sep 8.
PubMed 32898309Hustus, C., Evans, S.W., Owens, J.S., Benson, K.E., Hetrick, A., Kipperman, K. & DuPaul, G.J. (in press). An evaluation of 504 and individualized educational programs for high school students with attention-deficit/hyperactivity disorder. School Psychology Review.
Cleminshaw CL, DuPaul GJ, Kipperman KL, Evans SW, Owens JS. Social deficits in high school students with attention-deficit/hyperactivity disorder and the role of emotion dysregulation. Sch Psychol. 2020 Jul;35(4):233-242. doi: 10.1037/spq0000392.
PubMed 32673052DuPaul GJ, Evans SW, Cleminshaw-Mahan CL, Fu Q. School-Based Intervention for Adolescents With ADHD: Predictors of Effects on Academic, Behavioral, and Social Functioning. Behav Ther. 2024 Jul;55(4):680-697. doi: 10.1016/j.beth.2024.01.010. Epub 2024 Feb 13.
PubMed 38937043Evans SW, DuPaul GJ, Benson K, Owens JS, Fu Q, Cleminshaw C, Kipperman K, Margherio S. Social Functioning Outcomes of a High School-Based Treatment Program for Adolescents with ADHD. J Clin Child Adolesc Psychol. 2024 May-Jun;53(3):413-428. doi: 10.1080/15374416.2023.2235693. Epub 2023 Jul 26.
PubMed 37494306
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Study of School-based Treatment Approaches for Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT04480346
- Acronym / sponsor ID
- R305A140356 - 15
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Lehigh University
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Jul 2020 (actual)
- 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.
We evaluated the extent to which receiving the school-based multi-component treatment of the Challenging Horizons Program (CHP) would lead to significant improvements in levels of symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic functioning for high school aged adolescents diagnosed with ADHD. We intended to recruit 200 high school aged adolescents with a diagnosis of ADHD who would be randomly assigned to either CHP or a Community Care condition within each of 12 participating high schools. Outcome measures included parent, teacher and adolescent reports as well as observational data. Measures were collected at initial evaluations which preceded the one academic year of treatment, during the treatment period, and at six-months after treatment ended. Based on previous research with this treatment in middle and high schools, we anticipated meaningful gains for those in the treatment condition at post-treatment and larger gains on some variables at the 6-month follow-up evaluation.
Detailed description
We evaluated the extent to which receiving the school-based multi-component treatment of the Challenging Horizons Program (CHP) would lead to significant improvements in levels of symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic functioning for high school aged adolescents diagnosed with ADHD. We intended to recruit 200 high school aged adolescents with a diagnosis of ADHD who would be randomly assigned to either CHP or a Community Care condition within each of 12 participating high schools. Outcome measures included parent, teacher and adolescent reports as well as observational data. Measures were collected at initial evaluations which preceded the one academic year of treatment, during the treatment period, and at six-months after treatment ended. Based on previous research with this treatment in middle and high schools, we anticipated meaningful gains for those in the treatment condition at post-treatment and larger gains on some variables at the 6-month follow-up evaluation. Eligible participants were stratified for medication status and sex following the completion of all eligibility assessments for each of 3 cohorts and were randomly assigned (within schools) to either the CHP or CC condition. Siblings were assigned together such that they would be in the same condition. All measures (except the achievement test which was given at eligibility and post-treatment assessment points) were administered on at least three occasions including pre-treatment (i.e., eligibility or baseline), post-treatment, and 6-month follow-up. Rating scales were completed online using REDCap (Harris et al., 2009) with the exception of the School Functioning Scale.
Participants randomized to the treatment group met with their coaches individually for approximately 15-20 minutes twice per week throughout the academic year, typically during lunch, study hall, or an elective class. Individual sessions included study skills, organization, problem solving, and interpersonal skills training. Ten, 90-minute group sessions were offered to adolescents and parents in the evenings and ran concurrently. The organization intervention occurred during each individual session. During initial sessions, students and coaches worked collaboratively to develop a system of organizing the student's binders or folders and tracking assignments in a daily planner or electronic calendar. Subsequent sessions included a binder and daily planner check in which the student's adherence to the system was recorded and then the student practiced addressing disorganization (e.g., put assignments in the correct folders, update planner). After meeting objective criteria for organization (e.g., at least 80% planner completion for two consecutive weeks), adolescents independently completed organization and planner checks under supervision by coaches.
Each month, coaches checked with students and school records regarding six areas of risk including tardiness, absenteeism, in-school disciplinary actions, out-of-school suspension, failing classes, and missing assignments. If students met a predetermined threshold for risk (e.g., 80% or fewer assignments turned in on time), then the student and coach had a problem-solving discussion. The goal was to both develop a solution to the relevant problem as well as teach students how to use problem-solving skills. The process included (1) defining the problem, (2) setting a goal, (3) brainstorming ways to achieve that goal, (4) selecting one or more of these solutions, (5) determining how to know if the plan is working, (6) setting a date to start implementation, and (7) setting a date to review the success of the plan. During a subsequent session, the coach and student reviewed the results of the plan relative to stated goals and determined if they should continue the plan or make changes. During individual sessions, students and coaches critically reviewed social events and the student's behavior in relation to goals. This was an extension of the evening sessions focused on ISG and involved applying the skills learned in the group meetings to individual social events in the participants' daily lives. For students who were not performing well on tests and quizzes, coaches provided study skills intervention. Coaches reviewed test-taking strategies regarding different styles of test questions (e.g., planning an outline for an essay question). Students were tested on these strategies to demonstrate mastery and then practice the skills on practice tests. Students also learned strategies for using flashcards and class notes effectively to prepare for tests. In the ten evening sessions offered for students the adolescents participated in an interpersonal skills group (ISG) to improve social skills. During the first group, students were introduced to the concepts of ideal self - how they want to be seen, and real self - how they really are seen. Students developed ideal self goals and practiced behaving in ways that aligned with these goals during games and activities and frequently reviewed progess with staff. Parents were offered 10 evening sessions concurrent with students' ISG. Program staff provided psychoeducation about ADHD and common difficulties faced by teenagers, including sleep hygiene. Parents also worked with project staff to develop a homework management plan that determined when students would complete homework each night and for how long.
Participants who were randomized to the CC condition were given a list of available resources in their community and received no services from research staff. Participants in both CC and the treatment condition were informed that they could receive any community services during the duration of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHP treatment | Experimental | Behavioral: Challenging Horizons ProgramParticipants assigned to this arm received the treatment described in another section. |
| Community Care | No intervention | –Participants randomly assigned to this condition received information about service providers in the community, but no services from the investigators. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- On phone screen with parent report a previous diagnosis of ADHD or elevated levels on at least 4 of 9 ADHD symptoms of inattention
- Meet diagnostic criteria for ADHD on structured diagnostic interview with parents or parent and teacher ratings of symptoms and impairment
- Demonstrate an IQ of 75 or greater on the Wechsler Abbreviated Scale of Intelligence - Second Edition
- Attend a participating high school
Key exclusion criteria (2 listed)
- Does not exceed critical threshold on adolescent self report of substance us on the Substance Abuse Subtle Screening Inventory
- Does not meet diagnostic criteria for bipolar disorder, psychosis, or obsessive-compulsive disorder
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 |
|---|---|---|
| Challenging Horizons ProgramIntervention delivered in high schools provided by school mental health professional over the course of an academic year with twice-weekly meetings with students and 10 evening group meetings with students and 10 group sessions with parents. | Behavioural | CHP treatment |
Primary outcome
ADHD symptoms
Time frame: Change from Baseline ADHD symptoms through study completion, an average of 9 months.
Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.
ADHD symptoms
Time frame: Change from Baseline ADHD symptoms through six months post treatment, an average of 15 months.
Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.
Social Skills
Time frame: Change from Baseline social skills through study completion, an average of 9 months.
Parent ratings on Social Skills Improvement System Rating Scale - parent rating version;There are 46 items on the social skills factor that are rated from 0 to 3 (range 0 to 138) with higher scores indicating better social skills. Scores are converted to age and sex based standard scores (M=100).
Social Skills
Time frame: Change from Baseline social skills through six months post treatment, an average of 15 months.
Parent ratings on Social Skills Improvement System Rating Scale - parent rating version;There are 46 items on the social skills factor that are rated from 0 to 3 (range 0 to 138) with higher scores indicating better social skills. Scores are converted to age and sex based standard scores (M=100).
Grade Point Average
Time frame: Change from Baseline grade point average through study completion, an average of 9 months
Average of grades assigned by school each grading period;Average calculated based on a 0 to 4 scale with higher GPA corresponding to higher grades.
Grade Point Average
Time frame: Change from Baseline grade point average through six months post treatment, an average of 15 months.
Average of grades assigned by school each grading period;Average calculated based on a 0 to 4 scale with higher GPA corresponding to higher grades.
Organization Skills
Time frame: Change from Baseline organization skills through study completion, an average of 9 months.
Parent ratings on the Children's Organization Skills Scale;This is a 66-item rating scale with three subscales including Task Planning (raw scores range from 6 to 24), Organizing Actions (raw scores range from 10 to 40), and Memory and Materials Management (raw scores range from 10 to 40). High scores indicate worse organization skills.
Organization Skills
Time frame: Change from Baseline organization skills through six months post treatment, an average of 15 months.
Parent ratings on the Children's Organization Skills Scale;This is a 66-item rating scale with three subscales including Task Planning (raw scores range from 6 to 24), Organizing Actions (raw scores range from 10 to 40), and Memory and Materials Management (raw scores range from 10 to 40). High scores indicate worse organization skills.
Homework Completion
Time frame: Change from Baseline Homework Completion through study completion, an average of 9 months.
Parent ratings on the Homework Problems Checklist;This is a 20 item scale with scores ranging from 0 to 60 and high scores indicate greater problems completing homework.
Homework Completion
Time frame: Change from Baseline Homework Completion through six months post treatment, an average of 15 months.
Parent ratings on the Homework Problems Checklist;This is a 20 item scale with scores ranging from 0 to 60 and high scores indicate greater problems completing homework.
Classroom Behavior and Academic Performance
Time frame: Change from Baseline classroom behavior and academic performance through study completion, an average of 9 months.
Teacher ratings on the School Functioning Scale;This is a 9-item scale designed to measure behavior and academic performance in secondary school classrooms with scores ranging from 9 to 47. One 4-item factor focuses on classroom engagement behaviors and performance on tests and quizzes and scores range from 4 to 20 with high scores indicating better performance. Three questions about disruptive behavior have a range of scores from 3 to 15 with high scores indicating more disruption. Two questions focusing on interpersonal relationships produce scores ranging from 2 to 12 with high scores indicating better relationships.
Classroom Behavior and Academic Performance
Time frame: Change from Baseline classroom behavior and academic performance through six months post treatment, an average of 15 months.
Teacher ratings on the School Functioning Scale;This is a 9-item scale designed to measure behavior and academic performance in secondary school classrooms with scores ranging from 9 to 47. One 4-item factor focuses on classroom engagement behaviors and performance on tests and quizzes and scores range from 4 to 20 with high scores indicating better performance. Three questions about disruptive behavior have a range of scores from 3 to 15 with high scores indicating more disruption. Two questions focusing on interpersonal relationships produce scores ranging from 2 to 12 with high scores indicating better relationships.
16 secondary outcomes
Emotion Regulation
Time frame: Change from Baseline emotion regulation through study completion, an average of 9 months.
Emotion Regulation
Time frame: Change from Baseline emotion regulation through six months post treatment, an average of 15 months.
Anxiety
Time frame: Change from Baseline anxiety through study completion, an average of 9 months.
Anxiety
Time frame: Change from Baseline anxiety through six months post treatment, an average of 15 months.
Depression
Time frame: Change from Baseline depression through study completion, an average of 9 months.
Depression
Time frame: Change from Baseline depression through six months post treatment, an average of 15 months.
School Performance
Time frame: Change from Baseline school performance through study completion, an average of 9 months.
School Performance
Time frame: Change from Baseline school performance through six months post treatment, an average of 15 months.
Symptoms of conduct disorder and oppositional defiant disorder
Time frame: Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through study completion, an average of 9 months.
Symptoms of conduct disorder and oppositional defiant disorder
Time frame: Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through six months post treatment, an average of 15 months.
Family relationships
Time frame: Change from Baseline family relationships through study completion, an average of 9 months.
Family relationships
Time frame: Change from Baseline family relationships through six months post treatment, an average of 15 months.
Parent stress
Time frame: Change from Baseline parent stress through study completion, an average of 9 months
Parent stress
Time frame: Change from Baseline parent stress through six months post treatment, an average of 15 months.
Academic Achievement
Time frame: Change from Baseline academic achievement through study completion, an average of 9 months.
Academic Achievement
Time frame: Change from Baseline academic achievement through six months post treatment, an average of 15 months.
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 24 Jul 2020.
- Background: PubMed 30690333Dawson AE, Wymbs BT, Evans SW, DuPaul GJ. Exploring how adolescents with ADHD use and interact with technology. J Adolesc. 2019 Feb;71:119-137. doi: 10.1016/j.adolescence.2019.01.004. Epub 2019 Jan 25.
- Background: PubMed 31045408DuPaul GJ, Evans SW, Allan D, Puzino K, Xiang J, Cooper J, Owens JS. High school teacher ratings of academic, social, and behavioral difficulties: Factor structure and normative data for the School Functioning Scale. Sch Psychol. 2019 Sep;34(5):479-491. doi: 10.1037/spq0000323. Epub 2019 May 2.
- Background: PubMed 30112924Bunford N, Dawson AE, Evans SW, Ray AR, Langberg JM, Owens JS, DuPaul GJ, Allan DM. The Difficulties in Emotion Regulation Scale-Parent Report: A Psychometric Investigation Examining Adolescents With and Without ADHD. Assessment. 2020 Jul;27(5):921-940. doi: 10.1177/1073191118792307. Epub 2018 Aug 16.
- Background: PubMed 32329399Margherio SM, Capps ER, Monopoli JW, Evans SW, Hernandez-Rodriguez M, Owens JS, DuPaul GJ. Romantic Relationships and Sexual Behavior Among Adolescents With ADHD. J Atten Disord. 2021 Aug;25(10):1466-1478. doi: 10.1177/1087054720914371. Epub 2020 Apr 24.
- Background: PubMed 32271054Margherio SM, Brickner MA, Evans SW, Sarno Owens J, DuPaul GJ, Allan NP. The role of emotion regulation in alcohol use among adolescents with attention-deficit/hyperactivity disorder. Psychol Addict Behav. 2020 Nov;34(7):772-782. doi: 10.1037/adb0000582. Epub 2020 Apr 9.
- Background: PubMed 32898309Monopoli WJ, Evans SW, Benson K, Allan NP, Owens JS, DuPaul GJ, Bunford N. Assessment of a conceptually informed measure of emotion dysregulation: Evidence of construct validity vis a vis impulsivity and internalizing symptoms in adolescents with ADHD. Int J Methods Psychiatr Res. 2020 Dec;29(4):1-14. doi: 10.1002/mpr.1826. Epub 2020 Sep 8.
- BackgroundHustus, C., Evans, S.W., Owens, J.S., Benson, K.E., Hetrick, A., Kipperman, K. & DuPaul, G.J. (in press). An evaluation of 504 and individualized educational programs for high school students with attention-deficit/hyperactivity disorder. School Psychology Review.
- Background: PubMed 32673052Cleminshaw CL, DuPaul GJ, Kipperman KL, Evans SW, Owens JS. Social deficits in high school students with attention-deficit/hyperactivity disorder and the role of emotion dysregulation. Sch Psychol. 2020 Jul;35(4):233-242. doi: 10.1037/spq0000392.
- Derived from this study: PubMed 38937043DuPaul GJ, Evans SW, Cleminshaw-Mahan CL, Fu Q. School-Based Intervention for Adolescents With ADHD: Predictors of Effects on Academic, Behavioral, and Social Functioning. Behav Ther. 2024 Jul;55(4):680-697. doi: 10.1016/j.beth.2024.01.010. Epub 2024 Feb 13.
- Derived from this study: PubMed 37494306Evans SW, DuPaul GJ, Benson K, Owens JS, Fu Q, Cleminshaw C, Kipperman K, Margherio S. Social Functioning Outcomes of a High School-Based Treatment Program for Adolescents with ADHD. J Clin Child Adolesc Psychol. 2024 May-Jun;53(3):413-428. doi: 10.1080/15374416.2023.2235693. Epub 2023 Jul 26.
- Individual participant dataSharing planned: Yes. IPD will be available after the main outcome studies are published. The Co-PIs will consider requests in relation to potential overlap with investigator team planned manuscripts and qualifications of person making the request.
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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.
Steven W Evans, Ph.D. principal investigator
Ohio University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Challenging Horizons Program in people with Attention Deficit Hyperactivity Disorder, run by Ohio University at 2 sites 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 4 inclusion and 2 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 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
ADHD symptoms (time frame: Change from Baseline ADHD symptoms through study completion, an average of 9 months.). The study lists 12 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 NCT04480346, which also lists 10 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 24 Jul 2020.