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CompletedNCT01686724Updated Jun 18, 2019

Study of the Collaborative Life Skills Program

An interventional study of Collaborative Life Skills Intervention (CLS) and Business As Usual in Attention Deficit Hyperactivity Disorder Symptoms, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2019-06-18.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
504
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder Symptoms

Keywords

  • Attention Deficit Hyperactivity Disorder
  • Psychosocial Intervention
  • Behavioral Intervention
  • School-home collaborative intervention
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 504 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
504 participants (actual)

Study arms

  • 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)

Interventions

  • BehavioralCollaborative 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.

  • OtherBusiness As Usual
06

What researchers measure

Primary outcomes

  1. Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.

    Time frame: change from baseline on ADHD symptoms at 12 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • University of California San Francisco
    San Francisco, California 94143, United States
08

References and documents

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. PubMed 29588050 ↗
  • 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. PubMed 27566117 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01686724
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Sep 18, 2012
Start date
Sep 2012
Primary completion
Nov 2015
Completion
Jun 2016
Last update
Jun 18, 2019

Study contacts

Linda Pfiffner, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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