Study of the Collaborative Life Skills Program

Efficacy of the Collaborative Life Skills Program

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 Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder Symptoms
• Intervention / Treatment: Other: Business As Usual; Behavioral: Collaborative Life Skills Intervention (CLS)

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Homework Problems Checklist (HPC)	change from baseline in homework problems at 12 weeks
Academic Competency Evaluation Scale (ACES)	change from baseline in ACES at 12 weeks
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
Children's Organizational Skills Scale (COSS)	change from baseline in COSS at 12 weeks
Children's Organizational Skills Scale (COSS)	change from baseline in COSS at 7 months
Observations of classroom/school behavior	change from baseline on observed on-task behavior at 12 weeks
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 12 weeks
Academic Achievement	change from baseline in academic achievement at 7 months
Social Skills Improvement Scale	change from baseline in social/behavioral functioning at 12 weeks
Social Skills Improvement Scale	change from baseline in social/behavioral functioning at 7 months
Test of Life Skills Knowledge	change from baseline in life skills knowledge at 12 weeks
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 12 weeks
Alabama Parenting Questionnaire	change from baseline in parenting practices at 7 months
Parenting Stress Index	change from baseline in parenting stress at 12 weeks
Parenting Stress Index	change from baseline in parenting stress at 7 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Publications and helpful links

General Publications

• Pfiffner LJ, Rooney ME, Jiang Y, Haack LM, Beaulieu A, McBurnett K. Sustained Effects of Collaborative School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. J Am Acad Child Adolesc Psychiatry. 2018 Apr;57(4):245-251. doi: 10.1016/j.jaac.2018.01.016. Epub 2018 Feb 8.
• Pfiffner LJ, Rooney M, Haack L, Villodas M, Delucchi K, McBurnett K. A Randomized Controlled Trial of a School-Implemented School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. J Am Acad Child Adolesc Psychiatry. 2016 Sep;55(9):762-70. doi: 10.1016/j.jaac.2016.05.023. Epub 2016 Jul 1.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (ESTIMATE): September 18, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Attention Deficit Hyperactivity Disorder; Behavioral Intervention; Psychosocial Intervention; School-home collaborative intervention
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: R324A120358