Attention Deficit Hyperactivity Disorder Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06129396 -
Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT04779333 -
Lifestyle Enhancement for ADHD Program 2
|
N/A | |
| Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
| Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
| Completed |
NCT04832737 -
Strength-based Treatment Approach for Adults With ADHD
|
N/A | |
| Recruiting |
NCT04631042 -
Developing Brain, Impulsivity and Compulsivity
|
||
| Recruiting |
NCT05048043 -
Development of a Game-supported Intervention
|
N/A | |
| Completed |
NCT03337646 -
Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
|
Phase 4 | |
| Not yet recruiting |
NCT06080373 -
Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial
|
N/A | |
| Not yet recruiting |
NCT06454604 -
Virtual Reality Treatment for Emerging Adults With ADHD
|
Phase 2 | |
| Not yet recruiting |
NCT06406309 -
Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
|
N/A | |
| Completed |
NCT02477280 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance
|
Phase 4 | |
| Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT02390791 -
New Technologies to Help Manage ADHD
|
N/A | |
| Completed |
NCT02780102 -
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
|
N/A | |
| Completed |
NCT02473185 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest
|
Phase 4 | |
| Completed |
NCT02555150 -
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
|
Phase 3 | |
| Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
| Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A | |
| Recruiting |
NCT04175028 -
Neuromodulation of Executive Function in the ADHD Brain
|
N/A |