Traditional Face to Face TrainingNCT05772858
Family Therapy Training and Implementation Platform (FTTIP): An Innovative Web-based Tool for Long-term Practice Improvement
A study testing Training on CIFFTA competencies using Family Therapy Training and Implementation Platform (FTTIP), Training on CIFFTA competencies using Training and Coaching as Usual (TCAU). and Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA). in people with Traditional Face to Face Training and Family Therapy Training and Implementation Platform (FTTIP), run by Training and Implementation Associates at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Traditional Face to Face Training, Family Therapy Training and Implementation Platform (FTTIP)
- What is being tested?
- Training on CIFFTA competencies using Family Therapy Training and Implementation Platform (FTTIP), Training on CIFFTA competencies using Training and Coaching as Usual (TCAU). and Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2022to 31 Mar 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Pacific Clinics
Los Angeles, California, 91748
Scott Fairhurst, PhD, sfairhurst@pacificclinics.org
- Recruiting
Miami Dade County Public Schools
Miami, Florida, 33132
Rhea Lee, M.S., 305-995-1020, rhealee@dadeschools.net
About this study
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?
Read more
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.
Read the detailed description
Family therapy has emerged as one of the most efficacious interventions for child and adolescent behavioral and psychiatric issues and for chronic health conditions. However, widespread implementation of family therapy is often hampered by high training costs, re-training needs following staff turnover, low agency readiness to support new practices, and training strategies that lack ongoing implementation support and are prohibitively expensive. To better address the treatment needs of children and families, and to address long standing training and implementation challenges, we developed an innovative Family Therapy Training and Implementation Platform (FTTIP). FTTIP: 1) is guided by advances in implementation science, agency readiness, and knowledge of what it takes to sustain an evidence-based treatment; 2) uses adaptive training and consultation processes that provide a dynamic and data-driven procedure in which a competency is taught, measured, and the success or failure of the learning informs the next step of training in real time; 3) provides interactive practice of skills in which the trainee records interventions in response to simulation and receives personalized feedback; and 4) provides optional learning paths that allow the learner to explore additional ways to master the skills. Our Phase I study demonstrated the feasibility of FTTIP and set the stage for a fully-powered multisite Phase II Randomized Controlled Trial that will investigate whether FTTIP is "not inferior" to traditional face-to-face training on all key domains, including trainee competencies, agency readiness, and client outcomes. The Phase II study aims to: 1) Complete learning, practice and competency testing paths that provide the learner multiple learning options and to increase the dynamic nature of the platform; 2) Demonstrate that 75 FTTIP trainees show improvement in all core family therapy competencies that are not inferior to 75 providers receiving traditional in-person family therapy training as tested using pre and post training measures in a clinical trial; 3) Demonstrate that 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; 4) Establish the process (e.g., initiation and delays in training new staff) and cost associated with training in each of the two conditions; 5) Demonstrate that 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. FTTIP's commercial application is that national, state, and local treatment services funders and providers will find FTTIP to be a highly cost effective, flexible, and engaging way to improve the quality of their evidence-based treatments (EBTs). By better preparing the nation's workforce on EBTs, and providing the support and coaching they need to reach full mastery, our FTTIP product has the potential to significantly improve the wellbeing and mental health in our nation and internationally.
- Conditions
- Traditional Face to Face Training, Family Therapy Training and Implementation Platform (FTTIP)
- Being tested
- Training on CIFFTA competencies using Family Therapy Training and Implementation Platform (FTTIP), Training on CIFFTA competencies using Training and Coaching as Usual (TCAU)., Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA)., Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP), Agency Engagement and Orientation as Usual
- Keywords
- Mental health, Family therapy, Mental health training
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on CIFFTA competencies using Family Therapy Training and Implementation Platform (FTTIP)Other
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.
Training on CIFFTA competencies using Training and Coaching as Usual (TCAU).Other
Therapists receive training using the traditional face to-face training method for 2.5 days followed by coaching.
Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA).Other
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.
Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP)Other
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.
Agency Engagement and Orientation as UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Family Therapy Training and Implementation Platform (FTTIP) | Experimental | 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. Receives: Other: Training on CIFFTA competencies using Family Therapy Training and Implementation Platform (FTTIP) |
| Traditional in person Training as Usual | Active comparator | Participants will attend 20 hours of a traditional in person training learning about the family therapy evidenced based treatment. Receives: Other: Training on CIFFTA competencies using Training and Coaching as Usual (TCAU). |
| Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA). | Experimental | 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. Receives: Other: Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA). |
| Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP) | Experimental | 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 Receives: Other: Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP) |
| Agency Engagement and Orientation as Usual | Active comparator | 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. Receives: Other: Agency Engagement and Orientation as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in family therapy as measured by the number of sessions received by each study family
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Pre(baseline) and post organizational consultation (2 weeks)
Dates of the training process as measured by The Training Process Log
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.
Measured: 6 months
Optimization of technology platform will be measured using the Technology Optimization Log
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.
Measured: 4 months
Competency in evidenced based treatment as measured by CIFFTA Competencies Rating
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.
Measured: Pre-training phase and post-training phase (4 weeks later)
Secondary outcomes (4)
Therapeutic alliance as measured by the Working Alliance Inventory (WAI) short form
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.
Measured: At 5-6 weeks of treatment
Satisfaction with the CIFFTA evidenced based treatment as measured by a 10 question survey about satisfaction.
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.
Measured: At 5-6 weeks of treatment
Activities related to agency readiness as measured by The Organizational Readiness Consultation Activity Log
The Log will systematically document every activity related to agency readiness and issues that emerge related to agency readiness consultations.
Measured: 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
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.
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Apr 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traditional Face to Face TrainingStudies 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
- Model description
- 150 therapists will be randomly assigned to be trained by either the Family Therapy Training and Implementation Platform (FTTIP) or a Traditional in person Training as Usual (TAU). 150 families will all receive the Culturally Informed Flexible and Family based Treatment for Adolescents. 30 agency leaders will be randomly assigned to Family Therapy Training and Implementation Platform (FTTIP) agency readiness consultation or Agency readiness consultation as usual.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Training and Implementation Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Santisteban, PhD, Principal investigator, Training and Implementation AssociatesDaniel Santisteban, PhD, Study director, Training and Implementation Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772858
- Sponsor's protocol ID
- 1R43MH115547-01A1
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Therapy Training and Implementation Platform (FTTIP): An Innovative Web-based Tool for Long-term Practice Improvement
- ClinicalTrials.gov ID
- NCT05772858
- Acronym / sponsor ID
- 1R43MH115547-01A1
- Conditions
- Traditional Face to Face Training, Family Therapy Training and Implementation Platform (FTTIP)
- Keywords
- Mental health, Family therapy, Mental health training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Training and Implementation AssociatesUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 16 Mar 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.
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.
Detailed description
Family therapy has emerged as one of the most efficacious interventions for child and adolescent behavioral and psychiatric issues and for chronic health conditions. However, widespread implementation of family therapy is often hampered by high training costs, re-training needs following staff turnover, low agency readiness to support new practices, and training strategies that lack ongoing implementation support and are prohibitively expensive. To better address the treatment needs of children and families, and to address long standing training and implementation challenges, we developed an innovative Family Therapy Training and Implementation Platform (FTTIP). FTTIP: 1) is guided by advances in implementation science, agency readiness, and knowledge of what it takes to sustain an evidence-based treatment; 2) uses adaptive training and consultation processes that provide a dynamic and data-driven procedure in which a competency is taught, measured, and the success or failure of the learning informs the next step of training in real time; 3) provides interactive practice of skills in which the trainee records interventions in response to simulation and receives personalized feedback; and 4) provides optional learning paths that allow the learner to explore additional ways to master the skills. Our Phase I study demonstrated the feasibility of FTTIP and set the stage for a fully-powered multisite Phase II Randomized Controlled Trial that will investigate whether FTTIP is "not inferior" to traditional face-to-face training on all key domains, including trainee competencies, agency readiness, and client outcomes. The Phase II study aims to: 1) Complete learning, practice and competency testing paths that provide the learner multiple learning options and to increase the dynamic nature of the platform; 2) Demonstrate that 75 FTTIP trainees show improvement in all core family therapy competencies that are not inferior to 75 providers receiving traditional in-person family therapy training as tested using pre and post training measures in a clinical trial; 3) Demonstrate that 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; 4) Establish the process (e.g., initiation and delays in training new staff) and cost associated with training in each of the two conditions; 5) Demonstrate that 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. FTTIP's commercial application is that national, state, and local treatment services funders and providers will find FTTIP to be a highly cost effective, flexible, and engaging way to improve the quality of their evidence-based treatments (EBTs). By better preparing the nation's workforce on EBTs, and providing the support and coaching they need to reach full mastery, our FTTIP product has the potential to significantly improve the wellbeing and mental health in our nation and internationally.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 150 therapists will be randomly assigned to be trained by either the Family Therapy Training and Implementation Platform (FTTIP) or a Traditional in person Training as Usual (TAU). 150 families will all receive the Culturally Informed Flexible and Family based Treatment for Adolescents. 30 agency leaders will be randomly assigned to Family Therapy Training and Implementation Platform (FTTIP) agency readiness consultation or Agency readiness consultation as usual.
| Arm | Type | Receives |
|---|---|---|
| Family Therapy Training and Implementation Platform (FTTIP) | Experimental | Other: Training on CIFFTA competencies using 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. |
| Traditional in person Training as Usual | Active comparator | Other: Training on CIFFTA competencies using Training and Coaching as Usual (TCAU).Participants will attend 20 hours of a traditional in person training learning about the family therapy evidenced based treatment. |
| Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA). | Experimental | Other: 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. |
| Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP) | Experimental | Other: 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 |
| Agency Engagement and Orientation as Usual | Active comparator | Other: Agency Engagement and Orientation as UsualAgency 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 on CIFFTA competencies using Family Therapy Training and Implementation Platform (FTTIP)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. | Other | Family Therapy Training and Implementation Platform (FTTIP) |
| Training on CIFFTA competencies using Training and Coaching as Usual (TCAU).Therapists receive training using the traditional face to-face training method for 2.5 days followed by coaching. | Other | Traditional in person Training as Usual |
| Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA).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. | Other | Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA). |
| Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP)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. | Other | Agency Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP) |
| Agency Engagement and Orientation as UsualWork 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. | Other | Agency Engagement and Orientation as Usual |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Therapeutic alliance as measured by the Working Alliance Inventory (WAI) short form
Time frame: 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
Activities related to agency readiness as measured by The Organizational Readiness Consultation Activity Log
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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.
David Santisteban, PhD principal investigator
Training and Implementation Associates
Daniel Santisteban, PhD study director
Training and Implementation Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on CIFFTA competencies using Family Therapy Training and Implementation Platform (FTTIP), Training on CIFFTA competencies using Training and Coaching as Usual (TCAU). and Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA). in people with Traditional Face to Face Training and Family Therapy Training and Implementation Platform (FTTIP), run by Training and Implementation Associates 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Gutierrez, M.S.Ed. (305-986-2243, melissag@tiainternational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in family therapy as measured by the number of sessions received by each study family (time frame: Post therapy at 24 weeks). The study lists 7 primary outcomes in all. 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 16 Mar 2023.