Training of Mental Health ProfessionalsNCT02543359
A Statewide Trial to Compare Three Training Models for Implementing an Evidence-based Treatment (EBT)
A study testing Training Models of PCIT and Parent-Child Interaction Therapy (PCIT) Treatment in people with Training of Mental Health Professionals and Disruptive Behavior Disorders, run by West Virginia University at 1 site in United States.
Trial summary
Evidence-based treatments (EBTs) are available for treating Disruptive Behavior Disorders ( DBDs) including Parent-Child Interaction Therapy (PCIT). Despite EBTs' potential to help children and families, they have primarily remained in university settings. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Training of Mental Health Professionals, Disruptive Behavior Disorders
- What is being tested?
- Training Models of PCIT and Parent-Child Interaction Therapy (PCIT) Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 31 Dec 2017
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Administrators group
- must be employed at an agency selected to participate in training as an Executive Director, Chief Financial Officer, or other person responsible for daily operations.
- Clinicians/Supervisors group
- a masters or doctoral level professional in the human services field (e.g., social work, psychology, education),
- licensed in his/her field or receiving supervision from a licensed individual,
- actively seeing children and families who are appropriate for PCIT,
Show all 10Show fewer
- receptive to training in PCIT but not previously trained in PCIT,
- amenable to study tasks (e.g., video-taping, completing assessments).
- Parent-Child Dyads group
- Any parent-child dyad who a trained clinician enrolls in PCIT services
Who cannot join
- Administrators group
- not employed at an agency selected to participate in training as an Executive Director, Chief Financial Officer, or other person responsible for daily operations.
- Clinicians group
- a bachelors or lower level professional in the human services field,
- unlicensed in his/her field or not receiving supervision from a licensed individual,
- not actively seeing children and families who are appropriate for PCIT,
Show all 10Show fewer
- not receptive to training in PCIT but not previously trained in PCIT, and/or
- not amenable to study tasks. Interns also will be excluded.
- Parent-Child Dyads group
- if he/she is a ward of the state or living in state custody
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15203
About this study
Official title: A Statewide Trial to Compare Three Training Models for Implementing an EBT
Evidence-based treatments (EBTs) are available for treating Disruptive Behavior Disorders ( DBDs) including Parent-Child Interaction Therapy (PCIT). Despite EBTs' potential to help children and families, they have primarily remained in university settings. Recognized field leaders have expressed concern over the discrepancy between treatment research and clinical practice, and have indicated that EBT implementation is a priority. Little empirical evidence exists regarding how effective commonly used training models are in changing clinician behavior, achieving full implementation (e.g., increasing treatment fidelity, integrating into service settings), and supporting positive client outcomes. This novel application will evaluate the effectiveness of three training models (Learning Collaborative, Train-the-Trainer, and Web-Supported Self-Study) to implement a well-established EBT in real-world, community settings.
To accomplish this goal, the project will be guided by three specific aims:
Read more
- to build knowledge about training outcomes,
- to build knowledge about implementation outcomes, and
- to understand the impact of training clinicians using LC, TTT, and SS models on key client outcomes.
Seventy-two of 243 possible (30%) licensed psychiatric clinics across Pennsylvania will be randomized to one of three training conditions:
- Learning Collaborative (LC),
- Train-the-Trainer (TTT), or
- Web-Supported Self-Study (SS).
Data also will be collected on staff trained by clinicians in the TTT group given that the intention of a TTT model is for participants of that group to return to their organization and train others within the organization. The impact of training (clinician level) will be evaluated at 4 time-points coinciding with the training schedule: baseline, 6, 12, and 24-months. Immediately after training begins, parent-child dyads (client level) will be recruited from the caseloads of participating clinicians (N = 288). Client outcomes will be assessed at four timepoints (pre-treatment, 3, 6, and 12-months). Implementation outcomes (clinic level) will be assessed at baseline, 6, 12, and 24-months after training. This proposal builds on an ongoing state-led initiative to implement, and ultimately sustain, PCIT statewide. Lessons learned from this project will directly impact future EBT implementation efforts in Pennsylvania and other states, helping to increase the use of EBTs in community settings nationwide.
- Being tested
- Training Models of PCIT, Parent-Child Interaction Therapy (PCIT) Treatment
- Keywords
- Training, Implementation, Community-Based Mental Health Services, Parent-Child Interaction Therapy, Children
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Models of PCITBehavioural
Agency participants are trained in one of three training model strategies: Train the Trainer Model (TTT), Learning Collaborative (LC), or Web-Supported Self Study (SS).One third of participating agencies will be randomized to the Train the Trainer training model.One third of participating agencies will be randomized to the Learning Collaborative training model.One third of participating agencies will be randomized to the Web-Supported Self Study.
Training Models of PCITBehavioural
One-third of administrators are trained in the Learning Collaborative training model. One-third of administrators will be trained to usual treatment (none). One-third of administrators will be trained to usual treatment (none).
Parent-Child Interaction Therapy (PCIT) TreatmentBehavioural
Parent-Child Interaction Therapy (PCIT), a parent coaching evidence-based protocol is given to each family from clinicians and supervisors in each training model.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians and Supervisors | Experimental | After randomization clinicians and supervisors from community behavioral health agencies receive training in one of three PCIT training models: Train the Trainer (TTT), Learning Collaborative (LC) or Web-Supported Self Study (SS). Receives: Behavioral: Training Models of PCIT |
| Administrators | Experimental | After randomization administrators from participating community behavioral health agencies receive one of three treatments for PCIT (1/3 Learning Collaborative, 1/3 other treatment - none, and 1/3 other treatment - none). Receives: Behavioral: Training Models of PCIT |
| Parent-Child Dyads | Experimental | Parent-child dyads receive Parent-Child Interaction Therapy (PCIT) treatment from trained clinicians/supervisors. Receives: Behavioral: Parent-Child Interaction Therapy (PCIT) Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician knowledge of treatment based on PCIT Coaches Quiz
The PCIT Coaches Quiz measures clinicians' knowledge of PCIT concepts; a scale to assess clinicians' knowledge of PCIT concepts and coaching scenarios, and is a mixed question format of multiple choice and short answer. It was created by PCIT Developers based on training content.
Measured: Measured at baseline, 6, 12, and 24 months
Change in Clinician PCIT skill competency based on Therapist Competency Checklist
Therapist Competency Checklist evaluates competency criteria based on established Training Guidelines. The criteria are divided into five categories representing the full PCIT protocol (e.g., assessment, treatment, coaching). These pre-determined, skill-based competency items are rated by the trainer after observing trainees behavior over 1 year.
Measured: Measured at baseline and 6, 12, and 24 months
Change in Clinician attitudes about training based on Feedback Surveys
The following areas are measured: satisfaction with implementation condition,treatment acceptability,understanding, feasibility, and systems support; and satisfaction with training content, format, and presenters.
Measured: Measured at baseline and 6, 12 months and 24 months
Secondary outcomes (2)
Change in PCIT administrative interviews
Agency acceptability, adoption, appropriateness, cost feasibility, fidelity, penetration and sustainability of PCIT.
Measured: Measured at baseline and 6, 12 months and 24 months
Change in PCIT patient functioning
Family Outcome - Client mental health functioning (symptom improvement and daily functioning), treatment satisfaction, barriers to treatment, and service use (additional services and PCIT treatment process).
Measured: Measured at baseline, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2012
- Primary completion2 Nov 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Training of Mental Health ProfessionalsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amy Herschell, West Virginia University
- Investigators
- Amy D Herschell, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543359
- Sponsor's protocol ID
- PRO12060529
- Other IDs
- 5R01MH095750-02
- Status last verified
- Apr 2018
- First submitted
- 27 Aug 2015
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jackson CB, Macphee FL, Hunter LJ, Herschell AD, Carter MJ. Enrolling Family Participants in a Statewide Implementation Trial of an Evidence-Based Treatment. Prog Community Health Partnersh. 2017;11(3):233-241. doi: 10.1353/cpr.2017.0028.
PubMed 29056615Herschell AD, Scudder AB, Schaffner KF, Slagel LA. Feasibility and Effectiveness of Parent-Child Interaction Therapy with Victims of Domestic Violence: A Pilot Study. J Child Fam Stud. 2017 Jan;26(1):271-283. doi: 10.1007/s10826-016-0546-y. Epub 2016 Sep 19.
PubMed 28503060Herschell AD, Kolko DJ, Scudder AT, Taber-Thomas S, Schaffner KF, Hiegel SA, Iyengar S, Chaffin M, Mrozowski S. Protocol for a statewide randomized controlled trial to compare three training models for implementing an evidence-based treatment. Implement Sci. 2015 Sep 28;10:133. doi: 10.1186/s13012-015-0324-z.
PubMed 26416029Scudder AT, Taber-Thomas SM, Schaffner K, Pemberton JR, Hunter L, Herschell AD. A mixed-methods study of system-level sustainability of evidence-based practices in 12 large-scale implementation initiatives. Health Res Policy Syst. 2017 Dec 7;15(1):102. doi: 10.1186/s12961-017-0230-8.
PubMed 29216886Herschell AD, Kolko DJ, Scudder AT, Taber-Thomas SM, Schaffner KF, Hart JA, Mrozowski SJ, Hiegel SA, Iyengar S, Metzger A, Jackson CB. A Statewide Randomized Controlled Trial to Compare Three Models for Implementing Parent Child Interaction Therapy. J Clin Child Adolesc Psychol. 2023 Nov-Dec;52(6):780-796. doi: 10.1080/15374416.2021.2001745. Epub 2021 Dec 20.
PubMed 34928748
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Statewide Trial to Compare Three Training Models for Implementing an EBT
- ClinicalTrials.gov ID
- NCT02543359
- Acronym / sponsor ID
- PRO12060529
- Keywords
- Training, Implementation, Community-Based Mental Health Services, Parent-Child Interaction Therapy, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2012
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 7 Sep 2015 (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.
Evidence-based treatments (EBTs) are available for treating Disruptive Behavior Disorders ( DBDs) including Parent-Child Interaction Therapy (PCIT). Despite EBTs' potential to help children and families, they have primarily remained in university settings. Recognized field leaders have expressed concern over the discrepancy between treatment research and clinical practice, and have indicated that EBT implementation is a priority. Little empirical evidence exists regarding how effective commonly used training models are in changing clinician behavior, achieving full implementation (e.g., increasing treatment fidelity, integrating into service settings), and supporting positive client outcomes. This novel application will evaluate the effectiveness of three training models (Learning Collaborative, Train-the-Trainer, and Web-Supported Self-Study) to implement a well-established EBT in real-world, community settings.
To accomplish this goal, the project will be guided by three specific aims:
- to build knowledge about training outcomes,
- to build knowledge about implementation outcomes, and
- to understand the impact of training clinicians using LC, TTT, and SS models on key client outcomes.
Seventy-two of 243 possible (30%) licensed psychiatric clinics across Pennsylvania will be randomized to one of three training conditions:
- Learning Collaborative (LC),
- Train-the-Trainer (TTT), or
- Web-Supported Self-Study (SS).
Data also will be collected on staff trained by clinicians in the TTT group given that the intention of a TTT model is for participants of that group to return to their organization and train others within the organization. The impact of training (clinician level) will be evaluated at 4 time-points coinciding with the training schedule: baseline, 6, 12, and 24-months. Immediately after training begins, parent-child dyads (client level) will be recruited from the caseloads of participating clinicians (N = 288). Client outcomes will be assessed at four timepoints (pre-treatment, 3, 6, and 12-months). Implementation outcomes (clinic level) will be assessed at baseline, 6, 12, and 24-months after training. This proposal builds on an ongoing state-led initiative to implement, and ultimately sustain, PCIT statewide. Lessons learned from this project will directly impact future EBT implementation efforts in Pennsylvania and other states, helping to increase the use of EBTs in community settings nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinicians and Supervisors | Experimental | Behavioral: Training Models of PCITAfter randomization clinicians and supervisors from community behavioral health agencies receive training in one of three PCIT training models: Train the Trainer (TTT), Learning Collaborative (LC) or Web-Supported Self Study (SS). |
| Administrators | Experimental | Behavioral: Training Models of PCITAfter randomization administrators from participating community behavioral health agencies receive one of three treatments for PCIT (1/3 Learning Collaborative, 1/3 other treatment - none, and 1/3 other treatment - none). |
| Parent-Child Dyads | Experimental | Behavioral: Parent-Child Interaction Therapy (PCIT) TreatmentParent-child dyads receive Parent-Child Interaction Therapy (PCIT) treatment from trained clinicians/supervisors. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Administrators group
- must be employed at an agency selected to participate in training as an Executive Director, Chief Financial Officer, or other person responsible for daily operations.
- Clinicians/Supervisors group
- a masters or doctoral level professional in the human services field (e.g., social work, psychology, education),
- licensed in his/her field or receiving supervision from a licensed individual,
Key exclusion criteria (10 listed)
- Administrators group
- not employed at an agency selected to participate in training as an Executive Director, Chief Financial Officer, or other person responsible for daily operations.
- Clinicians group
- a bachelors or lower level professional in the human services field,
- unlicensed in his/her field or not receiving supervision from a licensed individual,
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 |
|---|---|---|
| Training Models of PCITAgency participants are trained in one of three training model strategies: Train the Trainer Model (TTT), Learning Collaborative (LC), or Web-Supported Self Study (SS).One third of participating agencies will be randomized to the Train the Trainer training model.One third of participating agencies will be randomized to the Learning Collaborative training model.One third of participating agencies will be randomized to the Web-Supported Self Study. | Behavioural | Clinicians and Supervisors |
| Training Models of PCITOne-third of administrators are trained in the Learning Collaborative training model. One-third of administrators will be trained to usual treatment (none). One-third of administrators will be trained to usual treatment (none). | Behavioural | Administrators |
| Parent-Child Interaction Therapy (PCIT) TreatmentParent-Child Interaction Therapy (PCIT), a parent coaching evidence-based protocol is given to each family from clinicians and supervisors in each training model. | Behavioural | Parent-Child Dyads |
Primary outcome
Change in Clinician knowledge of treatment based on PCIT Coaches Quiz
Time frame: Measured at baseline, 6, 12, and 24 months
The PCIT Coaches Quiz measures clinicians' knowledge of PCIT concepts; a scale to assess clinicians' knowledge of PCIT concepts and coaching scenarios, and is a mixed question format of multiple choice and short answer. It was created by PCIT Developers based on training content.
Change in Clinician PCIT skill competency based on Therapist Competency Checklist
Time frame: Measured at baseline and 6, 12, and 24 months
Therapist Competency Checklist evaluates competency criteria based on established Training Guidelines. The criteria are divided into five categories representing the full PCIT protocol (e.g., assessment, treatment, coaching). These pre-determined, skill-based competency items are rated by the trainer after observing trainees behavior over 1 year.
Change in Clinician attitudes about training based on Feedback Surveys
Time frame: Measured at baseline and 6, 12 months and 24 months
The following areas are measured: satisfaction with implementation condition,treatment acceptability,understanding, feasibility, and systems support; and satisfaction with training content, format, and presenters.
2 secondary outcomes
Change in PCIT administrative interviews
Time frame: Measured at baseline and 6, 12 months and 24 months
Change in PCIT patient functioning
Time frame: Measured at baseline, 3, 6 and 12 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 3 May 2018.
- Background: PubMed 29056615Jackson CB, Macphee FL, Hunter LJ, Herschell AD, Carter MJ. Enrolling Family Participants in a Statewide Implementation Trial of an Evidence-Based Treatment. Prog Community Health Partnersh. 2017;11(3):233-241. doi: 10.1353/cpr.2017.0028.
- Background: PubMed 28503060Herschell AD, Scudder AB, Schaffner KF, Slagel LA. Feasibility and Effectiveness of Parent-Child Interaction Therapy with Victims of Domestic Violence: A Pilot Study. J Child Fam Stud. 2017 Jan;26(1):271-283. doi: 10.1007/s10826-016-0546-y. Epub 2016 Sep 19.
- Background: PubMed 26416029Herschell AD, Kolko DJ, Scudder AT, Taber-Thomas S, Schaffner KF, Hiegel SA, Iyengar S, Chaffin M, Mrozowski S. Protocol for a statewide randomized controlled trial to compare three training models for implementing an evidence-based treatment. Implement Sci. 2015 Sep 28;10:133. doi: 10.1186/s13012-015-0324-z.
- Background: PubMed 29216886Scudder AT, Taber-Thomas SM, Schaffner K, Pemberton JR, Hunter L, Herschell AD. A mixed-methods study of system-level sustainability of evidence-based practices in 12 large-scale implementation initiatives. Health Res Policy Syst. 2017 Dec 7;15(1):102. doi: 10.1186/s12961-017-0230-8.
- Derived from this study: PubMed 34928748Herschell AD, Kolko DJ, Scudder AT, Taber-Thomas SM, Schaffner KF, Hart JA, Mrozowski SJ, Hiegel SA, Iyengar S, Metzger A, Jackson CB. A Statewide Randomized Controlled Trial to Compare Three Models for Implementing Parent Child Interaction Therapy. J Clin Child Adolesc Psychol. 2023 Nov-Dec;52(6):780-796. doi: 10.1080/15374416.2021.2001745. Epub 2021 Dec 20.
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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.
Amy D Herschell, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Models of PCIT and Parent-Child Interaction Therapy (PCIT) Treatment in people with Training of Mental Health Professionals and Disruptive Behavior Disorders, run by West Virginia University 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 10 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 3 May 2018. 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?
Change in Clinician knowledge of treatment based on PCIT Coaches Quiz (time frame: Measured at baseline, 6, 12, and 24 months). The study lists 3 primary outcomes in all. 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 NCT02543359, which also lists 5 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 3 May 2018.