NCT05772858

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

February 23, 2023

Last Update Submit

March 6, 2023

Conditions

Keywords

Mental healthFamily therapyMental health training

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    At 5-6 weeks of treatment

  • Satisfaction with the CIFFTA evidenced based treatment as measured by a 10 question survey about satisfaction.

    At 5-6 weeks of treatment

  • Activities related to agency readiness as measured by The Organizational Readiness Consultation Activity Log

    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

    At 4 weeks

Study Arms (5)

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.

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.

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.

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

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.

Other: Agency Engagement and Orientation as Usual

Interventions

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.

Family Therapy Training and Implementation Platform (FTTIP)

Therapists receive training using the traditional face to-face training method for 2.5 days followed by coaching.

Traditional in person Training as Usual

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.

Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA).

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 Readiness Consultation- Family Therapy Training and Implementation Platform (FTTIP)

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.

Agency Engagement and Orientation as Usual

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pacific Clinics

Los Angeles, California, 91748, United States

RECRUITING

Miami Dade County Public Schools

Miami, Florida, 33132, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • David Santisteban, PhD

    Training and Implementation Associates

    PRINCIPAL INVESTIGATOR
  • Daniel Santisteban, PhD

    Training and Implementation Associates

    STUDY DIRECTOR

Central Study Contacts

Melissa Gutierrez, M.S.Ed.

CONTACT

Alejandra Santisteban, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 16, 2023

Study Start

April 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations