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Completed

NCT Number: NCT01686724

Study 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.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collaborative Life Skills Intervention (CLS)

Behavioral

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.

Business as usual

Other

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Efficacy of the Collaborative Life Skills Program

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Sep 18, 2012
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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