Multisite Study of High School-based Treatment for Adolescents With ADHD

NCT04480346 | Completed

• 1 other identifier: R305A140356 - 15
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (12)

• ADHD symptoms

  Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.

  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.

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Change from Baseline classroom behavior and academic performance through six months post treatment, an average of 15 months.

Secondary Outcomes (16)

• Emotion Regulation

  Change from Baseline emotion regulation through study completion, an average of 9 months.

• Emotion Regulation

  Change from Baseline emotion regulation through six months post treatment, an average of 15 months.

• Anxiety

  Change from Baseline anxiety through study completion, an average of 9 months.

• Anxiety

  Change from Baseline anxiety through six months post treatment, an average of 15 months.

• Depression

  Change from Baseline depression through study completion, an average of 9 months.

Study Arms (2)

CHP treatment

EXPERIMENTAL

Participants assigned to this arm received the treatment described in another section.

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.

Interventions

Challenging Horizons Program BEHAVIORAL

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.

CHP treatment

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead
• Lehigh University: collaborator

Study Sites (2)

Ohio University

Athens, Ohio, 45701, United States

Location

Lehigh University

Bethlehem, Pennsylvania, 18015, United States

Location

Related Publications (10)

• 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.

  PMID: 30690333 BACKGROUND

• 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.

  PMID: 31045408 BACKGROUND

• 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.

  PMID: 30112924 BACKGROUND

• 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.

  PMID: 32329399 BACKGROUND

• 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.

  PMID: 32271054 BACKGROUND

• 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.

  PMID: 32898309 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32673052 BACKGROUND

• DuPaul 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.

  PMID: 38937043 DERIVED

• Evans 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.

  PMID: 37494306 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Steven W Evans, Ph.D.

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Psychology

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 21, 2020
• Study Start: March 1, 2015
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after main outcome studies are published.
• Access Criteria: Contact either of the Co-PIs (Evans \& DuPaul)

Locations

US (2)