ADHDCLS-RNCT05713331
Web-based Professional Development for SMHPs in Evidence-Based Practices for Attention and Behavior Challenges
A study testing CLS-R in people with ADHD, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This study develops a web-based PD (CLS-R) to provide SSWs with remote training in EBPs for attention and behavior problems. CLS-R is designed to be usable, feasible, portable, accessible, and acceptable - ingredients which have been identified as necessary for the sustainability of school-based programs. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- CLS-R
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2017to 30 Jun 2020
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 7-11, 2nd-5th grades
- Presence of academic and social problems related to inattention and/or hyperactivity/impulsivity (as judged by school SSW)
- Six or more inattention symptoms and/or six or more hyperactive/impulsive symptoms endorsed across parent and teacher rating scales (using an either-or algorithm, such that a symptom is counted as being present if either parent or teacher endorses it as occurring 'often' or 'very often')
- Functional impairment reported by either parent or teacher on the IRS (score of 3 or greater)
- Caretaker available and consents to participate in treatment
- Currently attending a participating school full-time
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
2 sites in 1 country.
United States2 sites
HALP Clinic, Children's Center at Langley Porter, UCSF
San Francisco, California, 94143
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Web-based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges
This study develops a web-based PD (CLS-R) to provide SSWs with remote training in EBPs for attention and behavior problems. CLS-R is designed to be usable, feasible, portable, accessible, and acceptable - ingredients which have been identified as necessary for the sustainability of school-based programs. The study evaluates the usability, feasibility, acceptability, fidelity of implementation, and preliminary effects on student outcomes.
Read the detailed description
- Title of Project: Web-Based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges
- RFA Topic and Goal: Social and Behavioral Context for Academic Learning, Goal 2
- Purpose: Development of a web-based professional development program (PD) for school mental health providers to gain the skills needed to implement evidence-based practices (EBPs) for attention and behavior problems.
- Setting: The research will be conducted in elementary schools within San Francisco Unified School District (SFUSD).
- Sample: Participants will include SFUSD school social workers (SSWs), students, parents and teachers.
- Professional Development to be developed: The Collaborative Life Skills (CLS) program will be developed into a web-based format (CLS-R) with all training and consultation provided remotely via videoconferencing. Includes EBP skill modules for consulting with teachers and parents and working with students directly.
- Control Condition: N/A
- Research design and methods: (1)Open Trials and Refinement: CLS-R will be field tested with 4 SSWs delivering the intervention to students, parents, and teachers. Modification and refinement of materials, manuals, and procedures will follow each trial based on questionnaire data and focus groups. Outcomes will evaluate usability, feasability, and acceptability, implementation fidelity, preliminary effects on student outcomes, and post-training sustainability of SSW EBP skill use. (2) Pilot Study: Using a randomized design, we will compare CLS-R and CLS. Six SSWs will receive CLS-R and 6 SSWs will receive CLS. To temporarily conduct study during COVID-19 school closures, we will test feasbility, usability and accesptability of the fully remote CLS parent component.
- Key measures: Measures of process (training fidelity, attendance), feasibility, usability, and acceptability will be obtained.
- Data analytic strategy: CLS-R usability and feasibility will focus on qualitative analysis of themes from focus groups, quantitative analyses of rating scales, and descriptive analyses of functionality.
- Conditions
- ADHD
- Being tested
- CLS-R
- 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.
CLS-RBehavioural
CLS-R Training includes school provider training in CLS via web platform and videoconferencing for workshops, consultation and coaching.CLS is a 10-12 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 and home.
| Study group | Role | What they receive |
|---|---|---|
| CLS-R | Experimental | Web-based remote training for school mental health providers Receives: Behavioral: CLS-R |
| CLS | Active comparator | In-person training for school mental health providers Receives: Behavioral: CLS-R |
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 DSMV
Parent and teacher rating scale
Measured: Change from baseline to post-treatment
Secondary outcomes (8)
Homework Problems Checklist (HPC)
Parent-rated scale
Measured: Change from baseline to post-treatment
Children's Organizational Skills Scale (COSS)
Parent and teacher rating scale
Measured: Change from baseline to post-treatment
Symptoms of Oppositional Defiant Disorder as defined by DSMV
Parent and teacher rating scale
Measured: Change from baseline to post-treatment
Strengths and Difficulties Questionnaire
Parent and teacher rating scale
Measured: Change from baseline to post-treatment
Clinical Global Improvement
Parent and teacher rating scale
Measured: Change from baseline to post-treatment
School Mental Health Provider Rating of Skill Competence, Motivation and Knowledge
School mental health provider rating scale
Measured: Change from baseline to post-treatment
Alabama Parenting Questionnaire
Parent rating scale
Measured: Change from baseline to post-treatment
Parenting Stress Index
Parent rating scale
Measured: Change from baseline to post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Sep 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: School closures during COVID-19 precluded study activities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences
- Responsible party
- Sponsor
- Investigators
- Linda Pfiffner, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713331
- Sponsor's protocol ID
- R305A170338
- Acronym
- CLS-R
- Status last verified
- Jan 2023
- First submitted
- 31 Oct 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung S, Lai J, Hawkey EJ, Dvorsky MR, Owens E, Huston E, Pfiffner LJ. Feasibility study of a telehealth school-based behavioral parent training group program for attention-deficit/hyperactivity disorder. J Pediatr Psychol. 2024 Oct 1;49(10):700-709. doi: 10.1093/jpepsy/jsae060.
PubMed 39186568
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges
- ClinicalTrials.gov ID
- NCT05713331
- Acronym / sponsor ID
- CLS-R / R305A170338
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: School closures during COVID-19 precluded study activities
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Institute of Education Sciences
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Feb 2023 (actual)
- 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 develops a web-based PD (CLS-R) to provide SSWs with remote training in EBPs for attention and behavior problems. CLS-R is designed to be usable, feasible, portable, accessible, and acceptable - ingredients which have been identified as necessary for the sustainability of school-based programs. The study evaluates the usability, feasibility, acceptability, fidelity of implementation, and preliminary effects on student outcomes.
Detailed description
- Title of Project: Web-Based Professional Development for School Mental Health Providers in Evidence-Based Practices for Attention and Behavior Challenges
- RFA Topic and Goal: Social and Behavioral Context for Academic Learning, Goal 2
- Purpose: Development of a web-based professional development program (PD) for school mental health providers to gain the skills needed to implement evidence-based practices (EBPs) for attention and behavior problems.
- Setting: The research will be conducted in elementary schools within San Francisco Unified School District (SFUSD).
- Sample: Participants will include SFUSD school social workers (SSWs), students, parents and teachers.
- Professional Development to be developed: The Collaborative Life Skills (CLS) program will be developed into a web-based format (CLS-R) with all training and consultation provided remotely via videoconferencing. Includes EBP skill modules for consulting with teachers and parents and working with students directly.
- Control Condition: N/A
- Research design and methods: (1)Open Trials and Refinement: CLS-R will be field tested with 4 SSWs delivering the intervention to students, parents, and teachers. Modification and refinement of materials, manuals, and procedures will follow each trial based on questionnaire data and focus groups. Outcomes will evaluate usability, feasability, and acceptability, implementation fidelity, preliminary effects on student outcomes, and post-training sustainability of SSW EBP skill use. (2) Pilot Study: Using a randomized design, we will compare CLS-R and CLS. Six SSWs will receive CLS-R and 6 SSWs will receive CLS. To temporarily conduct study during COVID-19 school closures, we will test feasbility, usability and accesptability of the fully remote CLS parent component.
- Key measures: Measures of process (training fidelity, attendance), feasibility, usability, and acceptability will be obtained.
- Data analytic strategy: CLS-R usability and feasibility will focus on qualitative analysis of themes from focus groups, quantitative analyses of rating scales, and descriptive analyses of functionality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLS-R | Experimental | Behavioral: CLS-RWeb-based remote training for school mental health providers |
| CLS | Active comparator | Behavioral: CLS-RIn-person training for school mental health providers |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children ages 7-11, 2nd-5th grades
- Presence of academic and social problems related to inattention and/or hyperactivity/impulsivity (as judged by school SSW)
- Six or more inattention symptoms and/or six or more hyperactive/impulsive symptoms endorsed across parent and teacher rating scales (using an either-or algorithm, such that a symptom is counted as being present if either parent or teacher endorses it as occurring 'often' or 'very often')
- Functional impairment reported by either parent or teacher on the IRS (score of 3 or greater)
- Caretaker available and consents to participate in treatment
Key exclusion criteria (10 listed)
- Presence of conditions that are incompatible with this study's treatment:
- 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
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 |
|---|---|---|
| CLS-RCLS-R Training includes school provider training in CLS via web platform and videoconferencing for workshops, consultation and coaching.CLS is a 10-12 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 and home. | Behavioural | CLS, CLS-R |
Primary outcome
Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMV
Time frame: Change from baseline to post-treatment
Parent and teacher rating scale
8 secondary outcomes
Homework Problems Checklist (HPC)
Time frame: Change from baseline to post-treatment
Children's Organizational Skills Scale (COSS)
Time frame: Change from baseline to post-treatment
Symptoms of Oppositional Defiant Disorder as defined by DSMV
Time frame: Change from baseline to post-treatment
Strengths and Difficulties Questionnaire
Time frame: Change from baseline to post-treatment
Clinical Global Improvement
Time frame: Change from baseline to post-treatment
School Mental Health Provider Rating of Skill Competence, Motivation and Knowledge
Time frame: Change from baseline to post-treatment
Alabama Parenting Questionnaire
Time frame: Change from baseline to post-treatment
Parenting Stress Index
Time frame: Change from baseline to post-treatment
Results and safety
The study was stopped early (reason given: School closures during COVID-19 precluded study activities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 39186568Chung S, Lai J, Hawkey EJ, Dvorsky MR, Owens E, Huston E, Pfiffner LJ. Feasibility study of a telehealth school-based behavioral parent training group program for attention-deficit/hyperactivity disorder. J Pediatr Psychol. 2024 Oct 1;49(10):700-709. doi: 10.1093/jpepsy/jsae060.
- Individual participant dataSharing planned: No
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLS-R in people with ADHD, run by University of California, San Francisco at 2 sites 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: stopped early, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: School closures during COVID-19 precluded study activities). Results are not available in the source record.
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 DSMV (time frame: Change from baseline to post-treatment). 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 NCT05713331, which also lists 1 linked publication.
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 6 Feb 2023.