NCT01686724CompletedNot Applicable
Efficacy of the Collaborative Life Skills Program
University of California, San Francisco1 site in 1 country504 target enrollmentStarted: September 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 504
- Locations
- 1
- Primary Endpoint
- Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Attending a participating school and in 2-5th grade
- •Referral by LSP as a child with apparent ADHD-related problems
- •≥ 6 symptoms (item score ≥ 2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory
- •≥ 3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
- •FSIQ or VIQ ≥ 80 (necessary for cognitive demands of the child skills curriculum)
- •Caretaker consents to participate in treatment, child assents to participate
Exclusion Criteria
- •Presence of conditions that are incompatible with this study's treatment.
- •severe visual or hearing impairment,
- •severe language delay,
- •psychosis,
- •pervasive developmental disorder
- •Parent or child does not read or speak English or does not read or speak Spanish for our Spanish language implementation of CLS (inability to complete assessment measures or participate in group treatments).
- •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 taking psychotropic medication for any reason other than to treat ADHD
- •Children planning to change (start or stop) psychotropic medication
- •Children who have changed a regimen of psychotropic medication (started or stopped) within 30 days prior to screening
Arms & Interventions
Business as Usual (BAU)
Other
This group receives services as usual in their schools. They will receive the intervention after follow-up measures are gathered.
Intervention: Business As Usual (Other)
Collaborative Life Skills Intervention (CLS)
Experimental
CLS 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.
Intervention: Collaborative Life Skills Intervention (CLS) (Behavioral)
Outcomes
Primary Outcomes
Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.
Time Frame: change from baseline on ADHD symptoms at 12 weeks
Secondary Outcomes
- Homework Problems Checklist (HPC)(change from baseline in homework problems at 7 months)
- Children's Organizational Skills Scale (COSS)(change from baseline in COSS at 7 months)
- Academic Competency Evaluation Scale (ACES)(change from baseline in ACES at 7 months)
- Academic achievement(change from baseline in academic achievement at 12 weeks)
- Parenting Stress Index(change from baseline in parenting stress at 7 months)
- Observations of classroom/school behavior(change from baseline in observed on-task behavior at 7 months)
- Academic Achievement(change from baseline in academic achievement at 7 months)
- Test of Life Skills Knowledge(change from baseline in life skills knowledge at 7 months)
- Alabama Parenting Questionnaire(change from baseline in parenting practices at 7 months)
- Social Skills Improvement Scale(change from baseline in social/behavioral functioning at 7 months)
- Academic Competency Evaluation Scale (ACES)(change from baseline in ACES at 12 weeks)
- Children's Organizational Skills Scale (COSS)(change from baseline in COSS at 12 weeks)
- Alabama Parenting Questionnaire(change from baseline in parenting practices at 12 weeks)
- Homework Problems Checklist (HPC)(change from baseline in homework problems at 12 weeks)
- Parenting Stress Index(change from baseline in parenting stress at 12 weeks)
- Observations of classroom/school behavior(change from baseline on observed on-task behavior at 12 weeks)
- Social Skills Improvement Scale(change from baseline in social/behavioral functioning at 12 weeks)
- Test of Life Skills Knowledge(change from baseline in life skills knowledge at 12 weeks)
Investigators
Study Sites (1)
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