Attention Deficit Hyperactivity Disorder SymptomsNCT01686724
Study of the Collaborative Life Skills Program
A study testing Collaborative Life Skills Intervention (CLS) and Business As Usual in people with Attention Deficit Hyperactivity Disorder Symptoms, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder Symptoms
- What is being tested?
- Collaborative Life Skills Intervention (CLS) and Business As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Efficacy 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.
- Being tested
- Collaborative Life Skills Intervention (CLS), Business As Usual
- Keywords
- Attention Deficit Hyperactivity Disorder, Psychosocial Intervention, Behavioral Intervention, School-home collaborative intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Life Skills Intervention (CLS)Behavioural
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 UsualOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Collaborative Life Skills Intervention (CLS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.
Measured: change from baseline on ADHD symptoms at 12 weeks
Secondary outcomes (18)
Homework Problems Checklist (HPC)
Measured: change from baseline in homework problems at 12 weeks
Academic Competency Evaluation Scale (ACES)
Measured: change from baseline in ACES at 12 weeks
Homework Problems Checklist (HPC)
Measured: change from baseline in homework problems at 7 months
Academic Competency Evaluation Scale (ACES)
Measured: change from baseline in ACES at 7 months
Children's Organizational Skills Scale (COSS)
Measured: change from baseline in COSS at 12 weeks
Children's Organizational Skills Scale (COSS)
Measured: change from baseline in COSS at 7 months
Observations of classroom/school behavior
Measured: change from baseline on observed on-task behavior at 12 weeks
Observations of classroom/school behavior
Measured: change from baseline in observed on-task behavior at 7 months
Academic achievement
Measured: change from baseline in academic achievement at 12 weeks
Academic Achievement
Measured: change from baseline in academic achievement at 7 months
Social Skills Improvement Scale
Measured: change from baseline in social/behavioral functioning at 12 weeks
Social Skills Improvement Scale
Measured: change from baseline in social/behavioral functioning at 7 months
Test of Life Skills Knowledge
Measured: change from baseline in life skills knowledge at 12 weeks
Test of Life Skills Knowledge
Measured: change from baseline in life skills knowledge at 7 months
Alabama Parenting Questionnaire
Measured: change from baseline in parenting practices at 12 weeks
Alabama Parenting Questionnaire
Measured: change from baseline in parenting practices at 7 months
Parenting Stress Index
Measured: change from baseline in parenting stress at 12 weeks
Parenting Stress Index
Measured: change from baseline in parenting stress at 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder SymptomsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Pfiffner, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686724
- Sponsor's protocol ID
- R324A120358
- Status last verified
- Jun 2019
- First submitted
- 16 Jul 2012
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29588050Pfiffner 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.
PubMed 27566117
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Collaborative Life Skills Program
- ClinicalTrials.gov ID
- NCT01686724
- Acronym / sponsor ID
- R324A120358
- Keywords
- Attention Deficit Hyperactivity Disorder, Psychosocial Intervention, Behavioral Intervention, School-home collaborative intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Business as Usual (BAU) | Other | Other: Business As UsualThis group receives services as usual in their schools. They will receive the intervention after follow-up measures are gathered. |
| Collaborative Life Skills Intervention (CLS) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- Presence of conditions that are incompatible with this study's treatment.
- severe visual or hearing impairment,
- severe language delay,
- psychosis,
- pervasive developmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Collaborative Life Skills Intervention (CLS) |
| Business As Usual | Other | Business as Usual (BAU) |
Primary outcome
Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.
Time frame: change from baseline on ADHD symptoms at 12 weeks
18 secondary outcomes
Homework Problems Checklist (HPC)
Time frame: change from baseline in homework problems at 12 weeks
Academic Competency Evaluation Scale (ACES)
Time frame: change from baseline in ACES at 12 weeks
Homework Problems Checklist (HPC)
Time frame: change from baseline in homework problems at 7 months
Academic Competency Evaluation Scale (ACES)
Time frame: change from baseline in ACES at 7 months
Children's Organizational Skills Scale (COSS)
Time frame: change from baseline in COSS at 12 weeks
Children's Organizational Skills Scale (COSS)
Time frame: change from baseline in COSS at 7 months
Observations of classroom/school behavior
Time frame: change from baseline on observed on-task behavior at 12 weeks
Observations of classroom/school behavior
Time frame: change from baseline in observed on-task behavior at 7 months
Academic achievement
Time frame: change from baseline in academic achievement at 12 weeks
Academic Achievement
Time frame: change from baseline in academic achievement at 7 months
Social Skills Improvement Scale
Time frame: change from baseline in social/behavioral functioning at 12 weeks
Social Skills Improvement Scale
Time frame: change from baseline in social/behavioral functioning at 7 months
Test of Life Skills Knowledge
Time frame: change from baseline in life skills knowledge at 12 weeks
Test of Life Skills Knowledge
Time frame: change from baseline in life skills knowledge at 7 months
Alabama Parenting Questionnaire
Time frame: change from baseline in parenting practices at 12 weeks
Alabama Parenting Questionnaire
Time frame: change from baseline in parenting practices at 7 months
Parenting Stress Index
Time frame: change from baseline in parenting stress at 12 weeks
Parenting Stress Index
Time frame: change from baseline in parenting stress at 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 29588050Pfiffner 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.
- Derived from this study: PubMed 27566117Pfiffner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Pfiffner, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Life Skills Intervention (CLS) and Business As Usual in people with Attention Deficit Hyperactivity Disorder Symptoms, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V. (time frame: change from baseline on ADHD symptoms at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.