Study of the Collaborative Life Skills Program

University of California San Francisco (UCSF)

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder Symptoms

Treatments: Behavioral: Collaborative Life Skills Intervention (CLS); Other: Business As Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT01686724

R324A120358

Details and patient eligibility

About

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.

Enrollment: 504 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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504 participants in 2 patient groups

Business as Usual (BAU)

Other group

Description:

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

Treatment:

Other: Business As Usual

Collaborative Life Skills Intervention (CLS)

Experimental group

Description:

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.

Treatment:

Behavioral: Collaborative Life Skills Intervention (CLS)