Substance-Related DisordersRAFTNCT01751217
Family Therapy Via Video Teleconference for Substance-Abusing Rural Adolescents
A study testing Functional Family Tx and Services as Usual in people with Substance-Related Disorders, run by Oregon Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Functional Family Tx and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Institute Center for Family and Adolescent Research
Albuquerque, New Mexico, 87102
About this study
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.
Read the 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.
- Conditions
- Substance-Related Disorders
- Being tested
- Functional Family Tx, Services as Usual
- Keywords
- Substance Abuse, Adolescents, Families, Functional Family Therapy, Video, Teleconferencing, Telemedicine
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Family TxBehavioural
Also called FFT
Services as UsualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12-months after randomization
Secondary outcomes (1)
Urine Assays - NIDA 9 Test Panel
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).
Measured: up to 12-months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startFeb 2012
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy J Ozechowski, Ph.D., Principal investigator, Oregon Research Institute's Center for Family and Adolescent ResearchHolly B Waldron, Ph.D, Principal investigator, Oregon Research Institute's Center for Family and Adolescent Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751217
- Sponsor's protocol ID
- 1R01DA032260-01A1
- Acronym
- RAFT
- Status last verified
- Aug 2017
- First submitted
- 13 Dec 2012
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Therapy Via Video Teleconference for Substance-Abusing Rural Adolescents
- ClinicalTrials.gov ID
- NCT01751217
- Acronym / sponsor ID
- RAFT / 1R01DA032260-01A1
- Conditions
- Substance-Related Disorders
- Keywords
- Substance Abuse, Adolescents, Families, Functional Family Therapy, Video, Teleconferencing, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Funct Family Tx/Video Teleconf (FFT-V) | Experimental | Behavioral: Functional Family TxFunctional 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. |
| Functional Family Tx | Experimental | Behavioral: Functional Family TxFunctional 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. |
| Services as Usual | Active comparator | Behavioral: Services as UsualThe 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Family TxAlso: FFT | Behavioural | Funct Family Tx/Video Teleconf (FFT-V), Functional Family Tx |
| Services as Usual | Behavioural | Services as Usual |
Primary outcome
Timeline Followback semi-structured interview (TLFB)
Time frame: Up to 12-months after randomization
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.
1 secondary outcome
Urine Assays - NIDA 9 Test Panel
Time frame: up to 12-months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy J Ozechowski, Ph.D. principal investigator
Oregon Research Institute's Center for Family and Adolescent Research
Holly B Waldron, Ph.D principal investigator
Oregon Research Institute's Center for Family and Adolescent Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Family Tx and Services as Usual in people with Substance-Related Disorders, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeline Followback semi-structured interview (TLFB) (time frame: Up to 12-months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.