Study of the Collaborative Life Skills Program

NCT ID: NCT01686724

Last Updated: 2019-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Business as Usual (BAU)

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

Group Type OTHER

Business As Usual

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Collaborative Life Skills Intervention (CLS)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Business As Usual

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Pfiffner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29588050 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27566117 (View on PubMed)

Other Identifiers

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R324A120358

Identifier Type: -

Identifier Source: org_study_id

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