Clinical trial NCT01686724: Study of the Collaborative Life Skills Program
Official title: Efficacy of the Collaborative Life Skills Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder Symptoms
Keywords: Attention Deficit Hyperactivity Disorder
Psychosocial Intervention
Behavioral Intervention
School-home collaborative intervention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 504
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.
timeFrame: change from baseline on ADHD symptoms at 12 weeks
Secondary outcomes:
measure: Homework Problems Checklist (HPC)
timeFrame: change from baseline in homework problems at 12 weeks
measure: Academic Competency Evaluation Scale (ACES)
timeFrame: change from baseline in ACES at 12 weeks
measure: Homework Problems Checklist (HPC)
timeFrame: change from baseline in homework problems at 7 months
measure: Academic Competency Evaluation Scale (ACES)
timeFrame: change from baseline in ACES at 7 months
measure: Children's Organizational Skills Scale (COSS)
timeFrame: change from baseline in COSS at 12 weeks
measure: Children's Organizational Skills Scale (COSS)
timeFrame: change from baseline in COSS at 7 months
measure: Observations of classroom/school behavior
timeFrame: change from baseline on observed on-task behavior at 12 weeks
measure: Observations of classroom/school behavior
timeFrame: change from baseline in observed on-task behavior at 7 months
measure: Academic achievement
timeFrame: change from baseline in academic achievement at 12 weeks
measure: Academic Achievement
timeFrame: change from baseline in academic achievement at 7 months
measure: Social Skills Improvement Scale
timeFrame: change from baseline in social/behavioral functioning at 12 weeks
measure: Social Skills Improvement Scale
timeFrame: change from baseline in social/behavioral functioning at 7 months
measure: Test of Life Skills Knowledge
timeFrame: change from baseline in life skills knowledge at 12 weeks
measure: Test of Life Skills Knowledge
timeFrame: change from baseline in life skills knowledge at 7 months
measure: Alabama Parenting Questionnaire
timeFrame: change from baseline in parenting practices at 12 weeks
measure: Alabama Parenting Questionnaire
timeFrame: change from baseline in parenting practices at 7 months
measure: Parenting Stress Index
timeFrame: change from baseline in parenting stress at 12 weeks
measure: Parenting Stress Index
timeFrame: change from baseline in parenting stress at 7 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Linda Pfiffner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.