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Family Therapy Via Video Teleconference for Substance-Abusing Rural Adolescents (RAFT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oregon Research Institute
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01751217
First received: December 13, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

The current proposal is a randomized clinical trial testing the efficacy of Functional Family Therapy (FFT) administered by video teleconference (FFT-V) in the homes of substance abusing adolescents. In the proposed investigation, FFT-V will be compared with FFT administered face-to-face in the family home as well as to a services-as-usual (SAU) condition. The overarching objective of the study is to examine the degree to which an empirically based model of substance abuse treatment such as FFT can be effectively administered via video teleconferencing to adolescents and families living in rural and remote areas who would be otherwise unlikely to access treatment. The specific aims of the proposed study are to (1) evaluate the efficacy of FFT-V compared to FFT and SAU in reducing adolescent drug use, HIV risk behavior, delinquency, and recidivism, (2) evaluate the efficacy of FFT-V compared to FFT in establishing functional levels of therapeutic alliance formation, treatment attendance, retention, and satisfaction with treatment, (3) evaluate the efficacy of FFT-V compared to FFT and SAU in impacting core mechanisms of change in adolescent behavior including improved levels of family functioning and adolescent association with substance using peers, and (4) conduct a preliminary cost-effectiveness analysis to derive initial estimates of the relative costs of each treatment modality per outcome unit.


Condition Intervention
Substance-Related Disorders
Behavioral: Functional Family Tx
Behavioral: Services as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family Therapy Via Video Teleconference for Substance-Abusing Rural Adolescents

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Timeline Followback semi-structured interview (TLFB) [ Time Frame: Up to 12-months after randomization ] [ Designated as safety issue: No ]
    The TLFB is a semi-structured interview pertaining to substance use behavior over a specific time interval (e.g., past 90 days). On each day of the assessment period, the type and amount of substance use is recorded based on retrospective self-reports. The interviewer utilizes a daily calendar and other types of memory aides to facilitate recall. At the pre-treatment assessment the TLFB will be used to assess the quantity and frequency of adolescent substance use during the 90 days prior to entry into the study. Days spent in a restrictive environment will be excluded from the baseline assessment period. At each post-treatment assessment, the calendar period will extend back to the date of the previous assessment. The TLFB will be used to determine the percent days of substance use excluding tobacco, as well as abstinence days and binge drinking days.


Secondary Outcome Measures:
  • Urine Assays - NIDA 9 Test Panel [ Time Frame: up to 12-months after randomization ] [ Designated as safety issue: No ]
    The NIDA 9 Test Panel is a card device with 9 finger-like prongs which are dipped in a urine sample to screen for AMP (amphetamine), BAR (barbiturates), BZO (benzodiazepines), COC (cocaine), M-AMP (metamphetamine), MTD (methadone), MOR (morphine), PCP, and THC (marijuana).


Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Funct Family Tx/Video Teleconf (FFT-V)
Functional Family Therapy (FFT) is a brief treatment for youth with problem behaviors, including substance abuse that consists of 12 to 14 weekly family sessions. The FFT treatment is applied in five distinct phases: Engagement, Motivation, Relational Assessment, Behavior Change, and Generalization and each phase has specific goals, techniques, and therapist skills. Adolescents and parents assigned to the FFT-V condition will receive a Verizon netbook laptop computer equipped with the Microsoft Windows 7 operating system, webcam, and VTC software for use in the family home. The VTC software is designed to stream live video between therapists and participants, to record video, and to store recorded videos as digital mpeg files. All family sessions will take place via video teleconference.
Behavioral: Functional Family Tx
Other Name: FFT
Experimental: Functional Family Tx
Functional Family Therapy (FFT) is a brief treatment for youth with problem behaviors, including substance abuse that consists of 12 to 14 weekly family sessions. The FFT treatment is applied in five distinct phases: Engagement, Motivation, Relational Assessment, Behavior Change, and Generalization and each phase has specific goals, techniques, and therapist skills. Families in the FFT condition will not be provided with the laptop and internet access described above. Instead, adolescents and parents in this condition will receive the FFT intervention face-to-face from an FFT therapist who will travel to the family home for each session.
Behavioral: Functional Family Tx
Other Name: FFT
Active Comparator: Services as Usual
The main CYFD service provider for adjudicated youth in both Sandoval and Valencia counties is Youth Development Incorporated (YDI) which is a private not-for-profit youth service organization serving adolescents in New Mexico . YDI provides an array of services for youth including tutoring, after-school activities, gang intervention, school drop-out prevention, family counseling services, an emergency teen shelter, parenting skills training, youth leadership development, community corrections services, GED studies, substance abuse and AIDS education, etc. The YDI juvenile corrections services include intensive supervision, educational and employment assistance, community service, victim restitution, and institutional transition services.
Behavioral: Services as Usual

Detailed Description:

It has been well documented that only about 10% of adolescents with clinically diagnosable substance use problems receive treatment in any given year. One of the major contributing factors to chronic levels of unmet need for treatment among this population is the unavailability and inaccessibility of treatment services. Service accessibility is particularly limited in rural areas. To address problems of service availability and accessibility in rural areas, the use of video teleconferencing technology to provide direct services has emerged within the fields of medicine and psychiatry in particular. The use of such technology to enhance the delivery of behavioral psychotherapy is beginning to emerge as well. A handful of primarily small-scale pilot and feasibility studies indicate that psychotherapy interventions administered using video teleconferencing technology may be as effective as traditional face-to-face interventions. Few randomized clinical trials of telepsychotherapy have been conducted to date, however, and virtually none have examined video teleconferencing interventions for any type of child or adolescent behavioral problem including substance abuse. The proposed study is intended to address the need for research evaluating the application of video teleconferencing technology as a means of service delivery for substance abusing adolescents and their families living in rural areas. Specifically, this study will examine the efficacy of Functional Family Therapy administered by video teleconference (FFT-V) in the homes of substance abusing adolescents. FFT-V will be compared with FFT administered face-to-face in the family home as well as to services-as-usual (SAU) coordinated through the Juvenile Services Division (JSD) of the State of New Mexico Children, Youth, and Families Department (CYFD). FFT, based on more than 30 years of research, is an established EBT for adolescent substance abuse and related problem behaviors such as HIV risk and delinquency. Moreover, FFT is one of few evidence-based therapies shown to be effective for rural families. The study will be conducted in the homes of participating adolescents and parents living in rural communities located between 30 and 50 miles from the Center for Family and Adolescent Research (CFAR) in Albuquerque, NM. One hundred and twenty youth will be referred to the study by Children Youth and Family Department juvenile probation officers within two rural counties in New Mexico, Sandoval and Valencia, which are adjacent to the town of Albuquerque which is located in Bernalillo County. Adolescent participants meeting diagnostic criteria for substance abuse or dependence, along with the participating parent, will be randomly assigned to the FFT, FFT-V, or SAU conditions. Four assessments of all participants in all three conditions will occur at: pre-treatment, 4-, 8-, and 12 months after treatment initiation. Outcome analyses will examine adolescent substance abuse, HIV risk behavior, delinquency, and recidivism, family functioning, and adolescent association with substance abusing peers. The study will also examine clinical process variables known to impact treatment efficacy (e.g., therapeutic alliance formation, treatment motivation, and retention). The overarching objective of the study is to examine the degree to which an empirically based model of substance abuse treatment such as FFT can be effectively administered via video teleconferencing to adolescents and families living in rural and remote areas and thus have less access to treatment.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 13-18 years of age
  • Meet DSM-IV diagnostic criteria for substance abuse or dependence
  • Reside with at least one parent or parental figure who is willing to participate in the study
  • Reside in a rural community approximately 30-50 miles from the CFAR office
  • Have sufficient residential stability to permit contact with CFAR throughout the study (e.g., not homeless or runaway at time of intake).

Exclusion Criteria:

  • Incarcerated or in a restrictive placement outside the home (e.g., residential treatment, in-patient care)
  • Evidence of a psychotic or organic state of sufficient severity to interfere with the ability to understand the research and clinical procedures
  • A sibling is already participating in the study
  • Evidence of posing a danger to self or others based on routine safety screening protocols (see Intake below)
  • Evidence that more intensive services other than outpatient treatment are required (e.g., in-patient care, detoxification).
  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: NCT01751217

Contacts
Contact: Timothy J Ozechowski, Ph.D. 505-842-8932 tozechowski@ori.org
Contact: Holly B Waldron, Ph.D. 505-842-8932 hwaldron@ori.org

Locations
United States, New Mexico
Oregon Research Institute Center for Family and Adolescent Research Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Janet L. Brody, Ph.D.    505-842-8932    jbrody@ori.org   
Sub-Investigator: Hyman Hops, Ph.D.         
Sub-Investigator: Janet L Brody, Ph.D.         
Sub-Investigator: Ed Feil, Ph.D.         
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Timothy J Ozechowski, Ph.D. Oregon Research Institute's Center for Family and Adolescent Research
Principal Investigator: Holly B Waldron, Ph.D Oregon Research Institute's Center for Family and Adolescent Development
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01751217     History of Changes
Other Study ID Numbers: 1R01DA032260-01A1
Study First Received: December 13, 2012
Last Updated: October 8, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Oregon Research Institute:
Substance Abuse
Adolescents
Families
Functional Family Therapy
Video
Teleconferencing
Telemedicine

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 27, 2014