Study of the Collaborative Life Skills Program

NCT01686724 | Completed

• 1 other identifier: R324A120358
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  change from baseline on ADHD symptoms at 12 weeks

Secondary Outcomes (18)

• 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

Study Arms (2)

Business as Usual (BAU)

OTHER

This group receives services as usual in their schools. They will receive the intervention after follow-up measures are gathered.

Other: Business As Usual

Collaborative Life Skills Intervention (CLS)

EXPERIMENTAL

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

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.

Collaborative Life Skills Intervention (CLS)

Business As Usual OTHER

Business as Usual (BAU)

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

• 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.

  PMID: 29588050 DERIVED

• 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.

  PMID: 27566117 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Commerce

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

• Linda Pfiffner, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: September 18, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

US (1)