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Behavioral Intervention
START Program for ADHD (START Trial)
N/A
Recruiting
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The child is between 6 and 12 years old
Be younger than 18 years old
Must not have
Participants who are not able to complete study procedures in English
Children under 6 and over 12 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if a program called START can increase access to treatment for ADHD and improve functioning for children and families. Participants will undergo a psychiatric evaluation before being assigned to either the START program or
Who is the study for?
This trial is for children aged 6-12 with a new or previously untreated ADHD diagnosis, confirmed by the study's psychiatrist. They must be able to understand and follow the study in English. Children treated for other conditions can join if it wasn't for ADHD.
What is being tested?
The START program aims to improve access to ADHD treatment and family functioning. It involves six sessions covering various modules, delivered by trained individuals. The effectiveness will be compared against controls who receive only an informational pamphlet.
What are the potential side effects?
Since START is a non-medical intervention involving educational modules, no direct medical side effects are expected from participation in this program.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 6 and 12 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot complete study procedures in English.
Select...
My child is either under 6 or over 12 years old.
Select...
My child was diagnosed with ADHD over 3 months ago and has started treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Attention-deficit/hyperactivity disorder (ADHD) Symptoms and Functioning
Attention-deficit/hyperactivity disorder (ADHD) Treatment Utilization
Secondary study objectives
ADHD School Services
ADHD Stages of Engagement Questionnaire
Attention-deficit/hyperactivity disorder (ADHD) Knowledge
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: START InterventionExperimental Treatment1 Intervention
Participants in the experimental group will be part of a 6-module weekly intervention where they will learn more about ADHD and its treatment.
Group II: Educational BrochureActive Control1 Intervention
Participants in the control group will receive an educational brochure by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).
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Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
273 Previous Clinical Trials
5,185,467 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
325 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)