Evidence Based PracticeNCT03799302
Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model
A study testing SIC Coaching in people with Evidence Based Practice, run by Oregon Social Learning Center at 1 site in United States.
Trial summary
This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Evidence Based Practice
- What is being tested?
- SIC Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Apr 2023
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize "technology-based approaches" for "implementing large-scale change." Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.
- Conditions
- Evidence Based Practice
- Being tested
- SIC Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIC CoachingBehavioural
Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC.
| Study group | Role | What they receive |
|---|---|---|
| Standard Consultation | No intervention | Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors |
| SIC Coaching Consultation | Experimental | In addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP. Receives: Behavioral: SIC Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of Implementation Completion (SIC)
The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability).
Measured: Baseline through month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Aug 2018
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence Based PracticeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Saldana, Oregon Social Learning Center
- Investigators
- Lisa Saldana, PHD, Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799302
- Sponsor's protocol ID
- R01DA044745
- Status last verified
- Oct 2023
- First submitted
- 13 Dec 2018
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model
- ClinicalTrials.gov ID
- NCT03799302
- Acronym / sponsor ID
- R01DA044745
- Conditions
- Evidence Based Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 10 Jan 2019 (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 aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize "technology-based approaches" for "implementing large-scale change." Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Consultation | No intervention | –Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors |
| SIC Coaching Consultation | Experimental | Behavioral: SIC CoachingIn addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| SIC CoachingSites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC. | Behavioural | SIC Coaching Consultation |
Primary outcome
Stages of Implementation Completion (SIC)
Time frame: Baseline through month 60
The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability).
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 1 Nov 2023.
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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.
Lisa Saldana, PHD principal investigator
Oregon Social Learning Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIC Coaching in people with Evidence Based Practice, run by Oregon Social Learning Center 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 1 inclusion and 1 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 1 Nov 2023. 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?
Stages of Implementation Completion (SIC) (time frame: Baseline through month 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2023.