Completed
Efficacy of the Collaborative Life Skills Program
What is being tested
Business As Usual
+ Collaborative Life Skills Intervention (CLS)
OtherBehavioral
Who is being recruted
Mental Disorders+1
+ Attention Deficit and Disruptive Behavior Disorders
+ Neurodevelopmental Disorders
From 7 to 11 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: September 2012
Summary
Principal SponsorUniversity of California, San Francisco
Last updated: June 18, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.This study tests the effectiveness of a newly developed integrated school-home behavioral intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The intervention is implemented by school-based mental health professionals within school settings.
Principal SponsorUniversity of California, San Francisco
Last updated: June 18, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
504 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 7 to 11 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Mental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersAttention Deficit Disorder with Hyperactivity
Criteria
6 inclusion criteria required to participate
>= 3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
>= 6 symptoms (item score >= 2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory
Attending a participating school and in 2-5th grade
Caretaker consents to participate in treatment, child assents to participate
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10 exclusion criteria prevent from participating
Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings)
Children planning to change (start or stop) psychotropic medication
Children taking psychotropic medication for any reason other than to treat ADHD
Children who have changed a regimen of psychotropic medication (started or stopped) within 30 days prior to screening
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
This group receives services as usual in their schools.
They will receive the intervention after follow-up measures are gathered.
Group II
ExperimentalCLS is a 12-week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of California San Francisco
San Francisco, United StatesOpen University of California San Francisco in Google MapsCompletedOne Study Center