A Statewide Trial to Compare Three Training Models for Implementing an Evidence-based Treatment (EBT)

Disruptive Behavior Disorders Clinical Trial

Official title:

A Statewide Trial to Compare Three Training Models for Implementing an EBT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543359
• Other study ID #: PRO12060529
• Secondary ID: 5R01MH095750-02
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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:

1. to build knowledge about training outcomes,

2. to build knowledge about implementation outcomes, and

3. 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:

1. Learning Collaborative (LC),

2. Train-the-Trainer (TTT), or

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 648
• Est. completion date: December 31, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

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,

• 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

Exclusion Criteria:

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,

• 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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Disruptive Behavior Disorders
• Mental Disorders
• Problem Behavior
• Training of Mental Health Professionals

Intervention

Behavioral:
• Training Models of PCIT
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 PCIT
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) Treatment
Parent-Child Interaction Therapy (PCIT), a parent coaching evidence-based protocol is given to each family from clinicians and supervisors in each training model.

Locations

Country	Name	City	State
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
West Virginia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Herschell 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. — View Citation

Herschell 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. — View Citation

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. — View Citation

Scudder 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at baseline, 6, 12, and 24 months
Primary	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 at baseline and 6, 12, and 24 months
Primary	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 at baseline and 6, 12 months and 24 months
Secondary	Change in PCIT administrative interviews	Agency acceptability, adoption, appropriateness, cost feasibility, fidelity, penetration and sustainability of PCIT.	Measured at baseline and 6, 12 months and 24 months
Secondary	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 at baseline, 3, 6 and 12 months