NCT01751217

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

4.8 years

First QC Date

December 13, 2012

Last Update Submit

August 17, 2017

Conditions

Keywords

Substance AbuseAdolescentsFamiliesFunctional Family TherapyVideoTeleconferencingTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Timeline Followback semi-structured interview (TLFB)

    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.

    Up to 12-months after randomization

Secondary Outcomes (1)

  • Urine Assays - NIDA 9 Test Panel

    up to 12-months after randomization

Study Arms (3)

Funct Family Tx/Video Teleconf (FFT-V)

EXPERIMENTAL

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

Functional Family Tx

EXPERIMENTAL

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

Services as Usual

ACTIVE COMPARATOR

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

Interventions

Also known as: FFT
Funct Family Tx/Video Teleconf (FFT-V)Functional Family Tx
Services as Usual

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute Center for Family and Adolescent Research

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 17, 2012

Study Start

February 1, 2012

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations