NCT02097563

Brief Summary

The present study aims to :

  1. 1.compare different approaches (high intensity vs. low intensity) to training community providers (those who routinely treat young patients with bipolar disorder, psychosis, or sub-threshold high-risk conditions) on the implementation of family-focused treatment (FFT);
  2. 2.assess the cost of FFT training and implementation support; and
  3. 3.determine whether these different forms of clinician training are associated with different outcomes over 1 year among patients with early-onset mood and psychotic disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2014

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

4.6 years

First QC Date

March 24, 2014

Last Update Submit

March 23, 2020

Conditions

Mood DisordersPsychotic Disorders

Keywords

Mood DisordersPsychosisSubthresholdBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Therapist Competency and Adherence Rating

    This is a measure of how well the clinician administered family-focused treatment (FFT) based on ratings of audiotapes of family intervention sessions. These ratings are made every third session in both training conditions. This is an overall rating that can vary from 1 (nonadherent) to 7 (excellent adherence)

    One year

Secondary Outcomes (2)

  • Patient Health Questionnaire, 9

    1 year

  • Young Mania Rating Scale

    1 year

Study Arms (2)

High Intensity Training

EXPERIMENTAL

High intensity training: clinician attends a 6-hr live workshop in family-focused treatment techniques, and then, after taking on a case, gets weekly technical consultation sessions (by telephone) in FFT from an expert after every session;

Behavioral: High Intensity Training

Low Intensity Training

ACTIVE COMPARATOR

Low Intensity Training: clinician completes online workshop in FFT and then, after taking on a case, gets telephone consultation sessions after every third session.

Behavioral: Low Intensity Training

Interventions

High Intensity TrainingBEHAVIORAL

This is a training method involving a live workshop followed by high intensity technical consultation.

High Intensity Training
Low Intensity TrainingBEHAVIORAL

Clinicians complete an online workshop in family-focused therapy, followed by technical consultation sessions after every third session.

Low Intensity Training

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For patient participants:
  • Youth (13-17 years of age) and young adults (18-25 years of age) with the following:
  • Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of bipolar disorder (BD) type I or II;
  • DSM-5 diagnosis of schizophrenia, schizophreniform disorder, or psychosis not otherwise specified \[NOS\];
  • DSM-5 diagnosis of bipolar disorder, not elsewhere classified (formerly bipolar NOS; see criteria below); or
  • Research classification of ultra high-risk for psychosis.
  • at least one parent or step-parent with whom the subject lives is willing to participate in family treatment sessions;
  • the potential patient and relative(s) participants are able and willing to give written informed assent/consent to participate in the study.
  • works at one of the participating agencies (Harbor/UCLA, San Fernando Mental Health Center, Didi Hirsch Mental Health Services)
  • provides mental health care for youth or young adults with (or at risk for) bipolar or psychotic disorders
  • are licensed (medical, psychologist, clinical social work, marriage and family therapy) mental health provider or are eligible to be a licensed mental health provider (social work / psychology intern or extern, psychiatry resident, psychiatry child and adolescent psychiatry fellow) in the State of California working under the direct supervision of a licensed mental health professional.

You may not qualify if:

  • a DSM-5 diagnosis of autism or pervasive developmental disorder, by history or medical records;
  • evidence of mental retardation by history or medical records (IQ \< 70);
  • diagnosable and active substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment, although a lifetime history of substance or alcohol disorders can be present if the patient has been abstinent for at least 4 months;
  • a life-threatening medical disorder that requires immediate hospitalization or other emergency treatment;
  • evidence of current sexual or physical abuse of the child, and/or current domestic abuse between the adult partners. These situations usually require notification of the Department of Child Services and forms of treatment other than family therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Didi Hirsch Mental Health Services

Culver City, California, 90230, United States

Location

San Fernando Mental Health Center

Granada Hills, California, 91344, United States

Location

Harbor/UCLA Outpatient Psychiatry Porgram

Torrance, California, 90502, United States

Location

Related Publications (2)

  • Miklowitz DJ, Schneck CD, Singh MK, Taylor DO, George EL, Cosgrove VE, Howe ME, Dickinson LM, Garber J, Chang KD. Early intervention for symptomatic youth at risk for bipolar disorder: a randomized trial of family-focused therapy. J Am Acad Child Adolesc Psychiatry. 2013 Feb;52(2):121-31. doi: 10.1016/j.jaac.2012.10.007. Epub 2013 Jan 2.

    PMID: 23357439BACKGROUND

  • Miklowitz DJ, Weintraub MJ, Posta F, Denenny DM, Chung B. Effects of High- versus Low-Intensity Clinician Training on Implementation of Family-Focused Therapy for Youth with Mood and Psychotic Disorders. Fam Process. 2021 Sep;60(3):727-740. doi: 10.1111/famp.12646. Epub 2021 Mar 29.

    PMID: 33779991DERIVED

Related Links

MeSH Terms

Conditions

Mood DisordersPsychotic DisordersBipolar Disorder

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Mental DisordersSchizophrenia Spectrum and Other Psychotic DisordersBipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David J Miklowitz, Ph.D.

    UCLA Semel Institute

    PRINCIPAL INVESTIGATOR

  • Bowen Chung, M.D.

    Harbor/UCLA Outpatient Psychiatry Program

    STUDY DIRECTOR

  • Ira Lesser, M.D.

    Harbor/UCLA Outpatient Psychiatry Program

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 27, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

US(3)