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Study of the Collaborative Life Skills Program

This study is currently recruiting participants.
Verified September 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01686724
First received: July 16, 2012
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder Symptoms
 Behavioral: Collaborative Life Skills Intervention (CLS)
Other: Business As Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of the Collaborative Life Skills Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V. [ Time Frame: change from baseline on ADHD symptoms at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Homework Problems Checklist (HPC) [ Time Frame: change from baseline in homework problems at 12 weeks ] [ Designated as safety issue: No ]
  • Academic Competency Evaluation Scale (ACES) [ Time Frame: change from baseline in ACES at 12 weeks ] [ Designated as safety issue: No ]
  • Homework Problems Checklist (HPC) [ Time Frame: change from baseline in homework problems at 7 months ] [ Designated as safety issue: No ]
  • Academic Competency Evaluation Scale (ACES) [ Time Frame: change from baseline in ACES at 7 months ] [ Designated as safety issue: No ]
  • Children's Organizational Skills Scale (COSS) [ Time Frame: change from baseline in COSS at 12 weeks ] [ Designated as safety issue: No ]
  • Children's Organizational Skills Scale (COSS) [ Time Frame: change from baseline in COSS at 7 months ] [ Designated as safety issue: No ]
  • Observations of classroom/school behavior [ Time Frame: change from baseline on observed on-task behavior at 12 weeks ] [ Designated as safety issue: No ]
  • Observations of classroom/school behavior [ Time Frame: change from baseline in observed on-task behavior at 7 months ] [ Designated as safety issue: No ]
  • Academic achievement [ Time Frame: change from baseline in academic achievement at 12 weeks ] [ Designated as safety issue: No ]
  • Academic Achievement [ Time Frame: change from baseline in academic achievement at 7 months ] [ Designated as safety issue: No ]
  • Social Skills Improvement Scale [ Time Frame: change from baseline in social/behavioral functioning at 12 weeks ] [ Designated as safety issue: No ]
  • Social Skills Improvement Scale [ Time Frame: change from baseline in social/behavioral functioning at 7 months ] [ Designated as safety issue: No ]
  • Test of Life Skills Knowledge [ Time Frame: change from baseline in life skills knowledge at 12 weeks ] [ Designated as safety issue: No ]
  • Test of Life Skills Knowledge [ Time Frame: change from baseline in life skills knowledge at 7 months ] [ Designated as safety issue: No ]
  • Alabama Parenting Questionnaire [ Time Frame: change from baseline in parenting practices at 12 weeks ] [ Designated as safety issue: No ]
  • Alabama Parenting Questionnaire [ Time Frame: change from baseline in parenting practices at 7 months ] [ Designated as safety issue: No ]
  • Parenting Stress Index [ Time Frame: change from baseline in parenting stress at 12 weeks ] [ Designated as safety issue: No ]
  • Parenting Stress Index [ Time Frame: change from baseline in parenting stress at 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 504
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01686724     History of Changes
Other Study ID Numbers: R324A120358
Study First Received: July 16, 2012
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

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
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013