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Study of the Collaborative Life Skills Program

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ClinicalTrials.gov Identifier: NCT01686724
Recruitment Status : Unknown
Verified May 2014 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : September 18, 2012
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Attention Deficit Hyperactivity Disorder Symptoms Behavioral: Collaborative Life Skills Intervention (CLS) Other: Business As Usual

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of the Collaborative Life Skills Program
Study Start Date : September 2012
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Business as Usual (BAU)
This group receives services as usual in their schools. They will receive the intervention after follow-up measures are gathered.
Other: Business As Usual
Experimental: Collaborative Life Skills Intervention (CLS)
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.
Behavioral: Collaborative Life Skills Intervention (CLS)
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.


Outcome Measures

Primary Outcome Measures :
  1. Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V. [ Time Frame: change from baseline on ADHD symptoms at 12 weeks ]

Secondary Outcome Measures :
  1. Homework Problems Checklist (HPC) [ Time Frame: change from baseline in homework problems at 12 weeks ]
  2. Academic Competency Evaluation Scale (ACES) [ Time Frame: change from baseline in ACES at 12 weeks ]
  3. Homework Problems Checklist (HPC) [ Time Frame: change from baseline in homework problems at 7 months ]
  4. Academic Competency Evaluation Scale (ACES) [ Time Frame: change from baseline in ACES at 7 months ]
  5. Children's Organizational Skills Scale (COSS) [ Time Frame: change from baseline in COSS at 12 weeks ]
  6. Children's Organizational Skills Scale (COSS) [ Time Frame: change from baseline in COSS at 7 months ]
  7. Observations of classroom/school behavior [ Time Frame: change from baseline on observed on-task behavior at 12 weeks ]
  8. Observations of classroom/school behavior [ Time Frame: change from baseline in observed on-task behavior at 7 months ]
  9. Academic achievement [ Time Frame: change from baseline in academic achievement at 12 weeks ]
  10. Academic Achievement [ Time Frame: change from baseline in academic achievement at 7 months ]
  11. Social Skills Improvement Scale [ Time Frame: change from baseline in social/behavioral functioning at 12 weeks ]
  12. Social Skills Improvement Scale [ Time Frame: change from baseline in social/behavioral functioning at 7 months ]
  13. Test of Life Skills Knowledge [ Time Frame: change from baseline in life skills knowledge at 12 weeks ]
  14. Test of Life Skills Knowledge [ Time Frame: change from baseline in life skills knowledge at 7 months ]
  15. Alabama Parenting Questionnaire [ Time Frame: change from baseline in parenting practices at 12 weeks ]
  16. Alabama Parenting Questionnaire [ Time Frame: change from baseline in parenting practices at 7 months ]
  17. Parenting Stress Index [ Time Frame: change from baseline in parenting stress at 12 weeks ]
  18. Parenting Stress Index [ Time Frame: change from baseline in parenting stress at 7 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686724


Contacts
Contact: Linda Pfiffner, PhD 415-476-7418 lindap@lppi.ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Linda Pfiffner, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Linda Pfiffner, PhD University of California, San Francisco
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01686724     History of Changes
Other Study ID Numbers: R324A120358
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by University of California, San Francisco:
Attention Deficit Hyperactivity Disorder
Psychosocial Intervention
Behavioral Intervention
School-home collaborative intervention

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms