Clinical trial NCT04480346: Multisite Study of High School-based Treatment for Adolescents With ADHD
Official title: Multisite Study of School-based Treatment Approaches for Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: Lehigh University
First posted: 2020-07-21
Enrollment: 186
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: ADHD symptoms
timeFrame: Change from Baseline ADHD symptoms through study completion, an average of 9 months.
measure: ADHD symptoms
timeFrame: Change from Baseline ADHD symptoms through six months post treatment, an average of 15 months.
measure: Social Skills
timeFrame: Change from Baseline social skills through study completion, an average of 9 months.
measure: Social Skills
timeFrame: Change from Baseline social skills through six months post treatment, an average of 15 months.
measure: Grade Point Average
timeFrame: Change from Baseline grade point average through study completion, an average of 9 months
measure: Grade Point Average
timeFrame: Change from Baseline grade point average through six months post treatment, an average of 15 months.
measure: Organization Skills
timeFrame: Change from Baseline organization skills through study completion, an average of 9 months.
measure: Organization Skills
timeFrame: Change from Baseline organization skills through six months post treatment, an average of 15 months.
measure: Homework Completion
timeFrame: Change from Baseline Homework Completion through study completion, an average of 9 months.
measure: Homework Completion
timeFrame: Change from Baseline Homework Completion through six months post treatment, an average of 15 months.
measure: Classroom Behavior and Academic Performance
timeFrame: Change from Baseline classroom behavior and academic performance through study completion, an average of 9 months.
measure: Classroom Behavior and Academic Performance
timeFrame: Change from Baseline classroom behavior and academic performance through six months post treatment, an average of 15 months.
Secondary outcomes:
measure: Emotion Regulation
timeFrame: Change from Baseline emotion regulation through study completion, an average of 9 months.
measure: Emotion Regulation
timeFrame: Change from Baseline emotion regulation through six months post treatment, an average of 15 months.
measure: Anxiety
timeFrame: Change from Baseline anxiety through study completion, an average of 9 months.
measure: Anxiety
timeFrame: Change from Baseline anxiety through six months post treatment, an average of 15 months.
measure: Depression
timeFrame: Change from Baseline depression through study completion, an average of 9 months.
measure: Depression
timeFrame: Change from Baseline depression through six months post treatment, an average of 15 months.
measure: School Performance
timeFrame: Change from Baseline school performance through study completion, an average of 9 months.
measure: School Performance
timeFrame: Change from Baseline school performance through six months post treatment, an average of 15 months.
measure: Symptoms of conduct disorder and oppositional defiant disorder
timeFrame: Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through study completion, an average of 9 months.
measure: Symptoms of conduct disorder and oppositional defiant disorder
timeFrame: Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through six months post treatment, an average of 15 months.
measure: Family relationships
timeFrame: Change from Baseline family relationships through study completion, an average of 9 months.
measure: Family relationships
timeFrame: Change from Baseline family relationships through six months post treatment, an average of 15 months.
measure: Parent stress
timeFrame: Change from Baseline parent stress through study completion, an average of 9 months
measure: Parent stress
timeFrame: Change from Baseline parent stress through six months post treatment, an average of 15 months.
measure: Academic Achievement
timeFrame: Change from Baseline academic achievement through study completion, an average of 9 months.
measure: Academic Achievement
timeFrame: Change from Baseline academic achievement through six months post treatment, an average of 15 months.
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Ohio University
name: Steven W Evans, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: DuPaul 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.
citation: Bunford 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.
citation: Margherio 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.
citation: Margherio 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.
citation: Monopoli 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.
citation: Hustus, 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.
citation: 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.