Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial (BOOST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oregon Research Institute
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01614015
First received: May 29, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

The proposed effectiveness study examines differences in treatment outcomes of an observation-based supervision (BOOST) versus supervision as usual (SAU). The study will be implemented within 16 teams delivering FFT services at 11 sites in the California Institute of Mental Health (CIMH) system. The 16 FFT therapist teams will be randomly assigned either to BOOST or SAU. Each team will have 3 therapists who will treat 6 families for a total of 18 families per team. Thus, each condition will include 24 therapists who will treat 144 families. The project will be implemented in four staggered waves to establish a more even rate of data collection and treatment implementation to enhance the feasibility of the study by keeping staffing and project costs more constant across the 5-year project. Each wave will involve 4 FFT teams, 2 receiving BOOST and 2 receiving SAU. Teams will be randomized to supervision conditions. Outcome assessments of parents and adolescents will be conducted at baseline and at 4 months and 16 months after treatment initiation.


Condition Intervention Phase
Delinquency
Substance Abuse
Self Destructive Behavior
Behavioral: Supervision
Behavioral: Observational Supervision
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Changes in Substance Use [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Using V-Timeline Follow Back


Secondary Outcome Measures:
  • Changes in Delinquency [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Using Child Behavior Checklist and Youth Self Report

  • Changes Family Functioning [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Using Parent and Adolescent Report of Monitoring and Family Environment Scale


Estimated Enrollment: 636
Study Start Date: September 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supervision as Usual
Supervision as Usual
Behavioral: Supervision
SAU consists of a 1-hour weekly group supervision session with the clinical team (typically 3-6 therapists). The on-site supervisor also conducts individual supervision sessions with each member of the clinical team. As such, the usual FFT supervision practice involves each therapist receiving two hours of supervision per week (one hour of group, one hour of individual). Supervision sessions are conducted by an on-site supervisor who has received intensive training in FFT supervision. The on-site supervisor also continues to receive feedback and guidance from a national consultant (FFT LLC) for one hour per month.
Other Name: SAU
Experimental: Observation Based Supervision
Behavioral
Behavioral: Observational Supervision
One intent of BOOST is to provide ongoing development of therapist clinical skills, and identify novel approaches to unique family circumstances that are consistent with FFT treatment. BOOST involves the BOOST supervisor reviewing the recorded therapy sessions prior to supervision sessions with the therapist and on-site FFT supervisor and weekly group and/or individual supervision meetings during which the BOOST supervisor provides feedback and coaching to the therapist. The goal of observation-based supervision is to ensure feedback to therapists is based on the supervisors' direct judgments about therapist behaviors, model adherence, and delivery of FFT services rather than relying solely on therapist self-report of session activities and interactions.
Other Name: BOOST

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. have at least one parent or parent figure (i.e., step-parent or surrogate) willing to participate;
  2. be 12 to 18 years of age (inclusive)
  3. be living at home with the participating parent
  4. have sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).

Exclusion Criteria:

  1. evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures
  2. has a sibling who is participating in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614015

Contacts
Contact: Michael S. Robbins, Ph.D. 541-484-2123 mrobbins@ori.org
Contact: Aleah Waldron 505-842-8932 ext 3116 aleah@ori.org

Locations
United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Principal Investigator: Holly B Waldron, Ph.D.         
Principal Investigator: Michael S. Robbins, Ph.D.         
Sponsors and Collaborators
Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01614015     History of Changes
Other Study ID Numbers: DA029406
Study First Received: May 29, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Research Institute:
Recording
Supervision
Observation

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014