Study of the Collaborative Life Skills Program

Attention Deficit Hyperactivity Disorder Symptoms Clinical Trial

Official title:

Efficacy of the Collaborative Life Skills Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686724
• Other study ID #: R324A120358
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: June 2016

Study information

• Verified date: June 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder Symptoms
• Hyperkinesis

Intervention

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.

Other:
• Business As Usual

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.		change from baseline on ADHD symptoms at 12 weeks
Secondary	Homework Problems Checklist (HPC)		change from baseline in homework problems at 12 weeks
Secondary	Academic Competency Evaluation Scale (ACES)		change from baseline in ACES at 12 weeks
Secondary	Homework Problems Checklist (HPC)		change from baseline in homework problems at 7 months
Secondary	Academic Competency Evaluation Scale (ACES)		change from baseline in ACES at 7 months
Secondary	Children's Organizational Skills Scale (COSS)		change from baseline in COSS at 12 weeks
Secondary	Children's Organizational Skills Scale (COSS)		change from baseline in COSS at 7 months
Secondary	Observations of classroom/school behavior		change from baseline on observed on-task behavior at 12 weeks
Secondary	Observations of classroom/school behavior		change from baseline in observed on-task behavior at 7 months
Secondary	Academic achievement		change from baseline in academic achievement at 12 weeks
Secondary	Academic Achievement		change from baseline in academic achievement at 7 months
Secondary	Social Skills Improvement Scale		change from baseline in social/behavioral functioning at 12 weeks
Secondary	Social Skills Improvement Scale		change from baseline in social/behavioral functioning at 7 months
Secondary	Test of Life Skills Knowledge		change from baseline in life skills knowledge at 12 weeks
Secondary	Test of Life Skills Knowledge		change from baseline in life skills knowledge at 7 months
Secondary	Alabama Parenting Questionnaire		change from baseline in parenting practices at 12 weeks
Secondary	Alabama Parenting Questionnaire		change from baseline in parenting practices at 7 months
Secondary	Parenting Stress Index		change from baseline in parenting stress at 12 weeks
Secondary	Parenting Stress Index		change from baseline in parenting stress at 7 months