Study of the Collaborative Life Skills Program

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder Symptoms

• Registration Number: NCT01686724
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-16
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-18
• Primary Completion: 2015-11
• Study Completion: 2016-06
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.	change from baseline on ADHD symptoms at 12 weeks

Secondary Outcome Measures

Name	Time	Method
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
Children's Organizational Skills Scale (COSS)	change from baseline in COSS at 7 months
Homework Problems Checklist (HPC)	change from baseline in homework problems 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
Social Skills Improvement Scale	change from baseline in social/behavioral functioning at 7 months

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States