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

NCT01614015 | Completed Phase 2 DMC

• 1 other identifier: DA029406
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delinquency; Substance Abuse; Self Destructive Behavior

Keywords

Recording; Supervision; Observation

Outcome Measures

Primary Outcomes (1)

• Changes in Substance Use

  Using V-Timeline Follow Back

  One Year

Secondary Outcomes (2)

• Changes in Delinquency

  One Year

• Changes Family Functioning

  One Year

Study Arms (2)

Supervision as Usual

EXPERIMENTAL

Supervision as Usual

Behavioral: Supervision

Observation Based Supervision

EXPERIMENTAL

Behavioral

Behavioral: Observational Supervision

Interventions

Supervision BEHAVIORAL

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.

Also known as: SAU

Supervision as Usual

Observational Supervision BEHAVIORAL

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.

Also known as: BOOST

Observation Based Supervision

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures
• has a sibling who is participating in the study

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Self-Injurious Behavior

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

• Michael S. Robbins, Ph.D.

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 7, 2012
• Study Start: September 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (1)