- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05772858
Family Therapy Training and Implementation Platform (FTTIP): An Innovative Web-based Tool for Long-term Practice Improvement
The goal of this clinical trial is to compare whether mental health therapists trained by a Family Therapy Training and Implementation Platform (FTTIP) or those trained in traditional face-to-face training differ on learning key family therapy domains, including competencies, agency readiness, and client outcomes. The main questions it aims to answer are:
- Will 75 FTTIP mental health therapists show improvement in all core family therapy competencies that are not inferior to 75 providers receiving traditional in person family therapy training?
- Will 150 families (child, parent, dyad) receiving CIFFTA family therapy show adequate retention in treatment therapeutic alliance and significant pre-post treatment improvements on family environment and presenting problems?
- Will 15 agency leaders receiving FTTIP agency readiness consultations show more pre and post change in agency readiness and knowledge than 15 leaders receiving agency engagement as usual?
Participants will participate in:
- Complete pre and post surveys
- 20 hours of training in an evidenced based family therapy treatment
- 24 weeks of biweekly coaching to implement the treatment
- 24 weeks of implementation of the treatment with one family
- Agency leaders will complete 2 weeks of organizational readiness engagement
Researchers will compare the Family Therapy Training and Implementation Platform (FTTIP) and traditional face-to-face training to see if FTTIP is not inferior to traditional training in key domains, including competencies, agency readiness, and client outcomes in mental health therapists.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Training on CIFFTA competencies using Family Therapy Training and Implementation Platform (FTTIP)
- Other: Training on CIFFTA competencies using Training and Coaching as Usual (TCAU).
- Other: Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA).
- Other: Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP)
- Other: Agency Engagement and Orientation as Usual
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melissa Gutierrez, M.S.Ed.
- Phone Number: 305-986-2243
- Email: melissag@tiainternational.org
Study Contact Backup
- Name: Alejandra Santisteban, MPH
- Phone Number: 305-984-7246
- Email: alejandra@tiainternational.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 91748
- Recruiting
- Pacific Clinics
-
Contact:
- Scott Fairhurst, PhD
- Email: sfairhurst@pacificclinics.org
-
-
Florida
-
Miami, Florida, United States, 33132
- Recruiting
- Miami Dade County Public Schools
-
Contact:
- Rhea Lee, M.S.
- Phone Number: 305-995-1020
- Email: rhealee@dadeschools.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 150 Bachelor's level counselors with 2 years of experience or Master's level counselors and therapists who have not had family therapy training in the past year and who are broadly representative of the potential trainees in the general population, including educational background and job experience with different client populations (e.g., varied demographics and presenting problems). All therapists must be actively providing treatment to youth and be willing to deliver the family intervention to at least one family during the project period.
- For each trainee that is part of the research study, we will select one client family (1 child and 1 caregiver) that we will assess and follow during the study. Once a trainee completes training and begins coaching, the next child/family that is assigned to the trainee, meets criteria for CIFFTA, and consent/assents to participate will be considered a participant in the study. The child must be between the ages of 11-18 years. Other than that, there are no exclusion of any specific age or age range group in the rest of the study participants (agency leaders, counselors)
- 30 leaders will be randomized to the two conditions. To be included in the study, agency leaders must have the authority to allocate agency resources (e.g., giving trainees protected time to participate in training activities, allowing smaller caseloads as they begin implementation) and be willing to participate in agency readiness and implementation consultation.
Exclusion Criteria:
- We are not limiting inclusion of any group by sex/gender, race, and/or ethnicity
- Agencies that are unwilling to participate in all study activities, that have nontraditional funding sources (e.g., totally charity funded), or that are so small they cannot assign sufficient counselors to the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Family Therapy Training and Implementation Platform (FTTIP)
Participants will be trained for 20 hours on an online platform practicing family therapy competencies with animated families and provided recorded video responses to receive feedback from trainers.
|
An Innovative Web-based Tool to train mental health therapists in family therapy competencies with animated families and provided recorded video responses to receive feedback from trainers.
|
|
Active Comparator: Traditional in person Training as Usual
Participants will attend 20 hours of a traditional in person training learning about the family therapy evidenced based treatment.
|
Therapists receive training using the traditional face to-face training method for 2.5 days followed by coaching.
|
|
Experimental: Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA).
All of the 150 families will receive Family Therapy, Individual Therapy, and Psycho-educational Modules, delivered over 16 weeks in a two session (60 minutes each) per week format.
|
CIFFTA has three major components: Family Therapy, Individual Therapy, and Psycho-educational Modules, delivered over 16 weeks in a two session (60 minutes each) per week format.
One session will typically be a family session which may include Family Therapy or Psychoeducational modules designed for the family or parents alone.
The other session is typically with the adolescent alone which may include individual treatment or Psycho-educational modules designed for the adolescent.
|
|
Experimental: Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP)
Agency leaders assigned to this condition will complete an online assessment of agency readiness, participate in a webinar and live discussion, complete an online meeting with leaders and clinical supervisors
|
The FTTIP agency readiness work begins with a pre-recorded FTTIP introduction webinar presented separately to each agency which presents overall goals of the project and the different FTTIP components, and key decisions agencies often make when seeking to sustain a new EBT.
|
|
Active Comparator: Agency Engagement and Orientation as Usual
Agency leaders assigned to this condition will receive a traditional engagement of leadership at their agency including a description of study procedures and engagement with study team.
|
Work with the agency leaders will consist of the traditional engagement of the leadership so that they agree to collaboration with the study team, with the training team, and with the study procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention in family therapy as measured by the number of sessions received by each study family
Time Frame: Post therapy at 24 weeks
|
A critically important measure when working with underserved populations are indicators of staying in treatment (avoiding premature termination).
The Retention measure will document the number of sessions received by each study family.
|
Post therapy at 24 weeks
|
|
Change from pre therapy to post therapy treatment in family cohesion and family conflict as measured by the Family Environment Scale
Time Frame: Pre therapy (at baseline) and post therapy at 24 weeks
|
This study will utilize two subscale of the Family Environment Scale, Family Cohesion and Family Conflict.
Each subscale consists of 9 true-false items yielding scores from 0-9.
The scales have been very useful in family therapy research and has strong psychometric properties.
Adolescent and caregiver will complete this measure.
|
Pre therapy (at baseline) and post therapy at 24 weeks
|
|
Change from pre therapy to post therapy treatment in adolescent behavior problems as measured by The Achenbach System of Empirically Based Assessments Brief Problem Monitoring (BPM) for 6-18 year old Scales
Time Frame: Pre therapy (at baseline) and post therapy at 24 weeks
|
The BPM's Internalizing (INT), Attention Problems (ATT), Externalizing (EXT), and Total Problems (TOT) scales comprise items from the Child Behavior Checklist for Ages 6-18, Teacher's Report Form (TRF), and Youth Self- Report (YSR).
The items, scales, and norms are based on decades of research and practical experience, as summarized in the BPM Manual.
For this study we will use the youth and caregiver reporting versions.
|
Pre therapy (at baseline) and post therapy at 24 weeks
|
|
Change in organizational readiness as measured by Training and Implementation Associates (TIA) Organizational Readiness Measure, Director Form
Time Frame: Pre(baseline) and post organizational consultation (2 weeks)
|
This assessment is intended to help TIA identify attitudes, processes and issues that can impact the success of adoption, implementation, and sustainment of a new practice.
The information guides our consultation with the agency leaders as we embark on training and implementation of a new evidence-based treatment.
The measure focuses on attitudes, knowledge, and current processes, values, and conditions within the agency and workforce.
|
Pre(baseline) and post organizational consultation (2 weeks)
|
|
Dates of the training process as measured by The Training Process Log
Time Frame: 6 months
|
The Training Process Log will capture the date that a trainee was hired, the date that the trainee received training, and how the agency handled the period between hiring and the formal training on the evidence-based treatment.
|
6 months
|
|
Optimization of technology platform will be measured using the Technology Optimization Log
Time Frame: 4 months
|
The Optimization Log will document the additional paths, learning competencies, new simulations, etc., that are created to ensure that all competencies have multiple paths and options for learning.
|
4 months
|
|
Competency in evidenced based treatment as measured by CIFFTA Competencies Rating
Time Frame: Pre-training phase and post-training phase (4 weeks later)
|
This measure is a modification of the Basic Skills Evaluation Device that was designed to evaluate family therapy competencies and document change.
Standard case vignettes are used to elicit interventions that are then rated.
The standardization of the clinical situation reduces variability and noise in rating competencies.
Our system is tailored to the specific competencies emphasized by CIFFTA but several are core family competencies.
These include reframing, blocking negative/hostile interactions, and highlighting caring and protective actions in the family as well as motivational enhancement and engagement interventions.
|
Pre-training phase and post-training phase (4 weeks later)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Therapeutic alliance as measured by the Working Alliance Inventory (WAI) short form
Time Frame: At 5-6 weeks of treatment
|
This alliance measure is one of the most recognized and used self-report measures of therapeutic alliance.
WAI is a 10-item measure of the quality and strength of the alliance between therapist and client on three dimensions: Goal, Task, and Bond.
Adolescents and caregiver will complete this self-report measure.
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At 5-6 weeks of treatment
|
|
Satisfaction with the CIFFTA evidenced based treatment as measured by a 10 question survey about satisfaction.
Time Frame: At 5-6 weeks of treatment
|
Clients will be asked 10 questions about their satisfaction with the different components of treatment, the involvement of family members, and the inclusion of cultural content in sessions.
The degree to which the work was useful will be scored on a 1-5 scale.
Adolescent and caregiver will complete it.
|
At 5-6 weeks of treatment
|
|
Activities related to agency readiness as measured by The Organizational Readiness Consultation Activity Log
Time Frame: Through study completion, an average of 1 year
|
The Log will systematically document every activity related to agency readiness and issues that emerge related to agency readiness consultations.
|
Through study completion, an average of 1 year
|
|
Usefulness of the platform for therapists as measured by Trainee Rating of Usefulness of the Platform and Confidence in Implementing Techniques
Time Frame: At 4 weeks
|
The Trainee Rating of Usefulness of the Platform and Confidence in Implementing Techniques is an online measure that is completed after each of the six CIFFTA competencies in the FTTIP online condition.
In addition to overall rating of satisfaction, four specific questions will be asked across all modules: How confident are you in your skills at performing the following?
How much more training and coaching would you like to receive in this area to master it?
How useful was the learning platform in introducing the concepts?
How useful was the platform in helping you practice?
The responses are rated on a 1-5 scale (e.g., 5 = Very Useful).
The responses to these questions were very valuable in the evaluation of the training modules.
|
At 4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Santisteban, PhD, Training and Implementation Associates
- Study Director: Daniel Santisteban, PhD, Training and Implementation Associates
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R43MH115547-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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