Family FunctioningNCT01944748
Family Mediation Program For At-Risk Youth
A study testing Families Able To Resolve Situations (FARS) in people with Family Functioning, run by RAND at 1 site in United States.
Trial summary
The goal of this project is to conduct a pilot evaluation of a parent-child mediation program for at-risk youth. It is investigating whether families who receive parent-child mediation show greater improvement in family functioning, as well as adolescent substance use, academic performance, and delinquency, over a… Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Family Functioning
- What is being tested?
- Families Able To Resolve Situations (FARS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Has a child referred to FARS due to having problems in any of the following areas: (a) poor grades; (b) truancy; (c) defiant behavior; (d) running away; (e) delinquency; (f) substance use
- Agrees to participate in at least one FARS mediation session
- Agrees to complete 3 surveys and be available over the next 3 months for follow-up
- Fluent in English or Spanish
- -
- Exclusion Criteria: Families referred to FARS due to: (a) conflicts involving gang violence (e.g., shootings, killings); (b) conflicts involving weapons; (c) arson; (d) conflicts involving explicit sex activities; (e) conflicts involving domestic violence/child abuse; and (f) threats to harm self or others.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centinela Youth Services
Hawthorne, California, 90250
About this study
The goal of this project is to conduct a pilot evaluation of a parent-child mediation program for at-risk youth. It is investigating whether families who receive parent-child mediation show greater improvement in family functioning, as well as adolescent substance use, academic performance, and delinquency, over a 6-week and 12-week period compared to a wait-list control sample.
- Conditions
- Family Functioning
- Being tested
- Families Able To Resolve Situations (FARS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families Able To Resolve Situations (FARS)Behavioural
Family mediation is a method of resolving conflicts between parents and teens. During the mediation session, the parent and teen each meet one-on-one with a trained volunteer mediator, who is a neutral person who listens to each party's concerns without taking sides. Then the parent and teen come together and meet with this mediator to work on resolving conflicts they are having. Families participate in up to 3 mediation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Family Mediation | Experimental | Families receive FARS family mediation program after completing baseline survey. Receives: Behavioral: Families Able To Resolve Situations (FARS) |
| Wait-list control | No intervention | Families receive FARS family mediation program after completing baseline, 6-week and 12-week surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Family Relations
6-item Positive Family Relations measure adapted from the Cohesion subscale of Moos \& Moos Family Environment Scale (Metzler et al., 1998; Journal of Family Psychology, 12, 600-619). Items are rated on a 5-point scale ("not at all" to "very much") and averaged to create a scale score.
Measured: 6-week
Family Conflict
5-item measure from the Family, Friends and Self (FFS) assessment scales (Simpson \& McBride, 1992; Hispanic Journal of Behavioral Sciences, 14, 327-340). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Measured: 6-week
Family Communication
10-item measure assessing open vs. problem communication (McCubbin, Thompson \& McCubbin, 1996; Family assessment: Resiliency, coping and adaptation - Inventories for research and practice. Madison, WI: University of Wisconsin). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Measured: 6-week
Parent Support
4-item measure (Wills et al., 2004; Psychology of Addictive Behaviors, 18, 122-134). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Measured: 6-week
Positive Family Relations
6-item Positive Family Relations measure adapted from the Cohesion subscale of Moos \& Moos Family Environment Scale (Metzler et al., 1998; Journal of Family Psychology, 12, 600-619). Items are rated on a 5-point scale ("not at all" to "very much") and averaged to create a scale score.
Measured: 12-week
Family Conflict
5-item measure from the Family, Friends and Self (FFS) assessment scales (Simpson \& McBride, 1992; Hispanic Journal of Behavioral Sciences, 14, 327-340). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Measured: 12-week
Family Communication
10-item measure assessing open vs. problem communication (McCubbin, Thompson \& McCubbin, 1996; Family assessment: Resiliency, coping and adaptation - Inventories for research and practice. Madison, WI: University of Wisconsin). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Measured: 12-week
Parent Support
4-item measure (Wills et al., 2004; Psychology of Addictive Behaviors, 18, 122-134). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Measured: 12-week
Secondary outcomes (6)
Lifetime and Past Month Substance Use
Number of times used in lifetime (range: "0 times" to "7 or more times") and number of days used in past month (range: "0 days" to "20-30-days") for each of the following substances: cigarettes; alcohol; marijuana; inhalants; any other illegal drug or pill to get high; over-the-counter medicines or OTCs to get high; and prescription medicines to get high.
Additional items ask about quantity of cigarette, alcohol and marijuana use on days used, as well as intentions to use each of these substances in next 6 months (4-point scale, ranging from "definitely yes" to "definitely no").
Measured: 6-week
Academic Performance
Items ask about typical grades in past month (range: "mostly A's" to "mostly F's"), school attachment (4-item measure from National Longitudinal Study of Adolescent Health), highest level of school the youth plans to finish (range: "I may not finish high school" to "I plan to go to graduate or professional school"), number of days skipped school in past month, and history of suspension from school.
Measured: 6-week
Delinquency
13-item measure that includes items from Project ALERT and National Longitudinal Study of Adolescent Health. Items are rated on a 7-point scale ("0 days" to "20-30 days").
Measured: 6-weeks
Lifetime and Past Month Substance Use
Number of times used in lifetime (range: "0 times" to "7 or more times") and number of days used in past month (range: "0 days" to "20-30-days") for each of the following substances: cigarettes; alcohol; marijuana; inhalants; any other illegal drug or pill to get high; over-the-counter medicines or OTCs to get high; and prescription medicines to get high.
Additional items ask about quantity of cigarette, alcohol and marijuana use on days used, as well as intentions to use each of these substances in next 6 months (4-point scale, ranging from "definitely yes" to "definitely no").
Measured: 12-week
Academic Performance
Items ask about typical grades in past month (range: "mostly A's" to "mostly F's"), school attachment (4-item measure from National Longitudinal Study of Adolescent Health), highest level of school the youth plans to finish (range: "I may not finish high school" to "I plan to go to graduate or professional school"), number of days skipped school in past month, and history of suspension from school.
Measured: 12-week
Delinquency
13-item measure that includes items from Project ALERT and National Longitudinal Study of Adolescent Health. Items are rated on a 7-point scale ("0 days" to "20-30 days").
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJul 2011
- Primary completionFeb 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family FunctioningStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan S. Tucker, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944748
- Sponsor's protocol ID
- R34DA031910
- Status last verified
- Apr 2016
- First submitted
- 3 Sep 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Mediation Program For At-Risk Youth
- ClinicalTrials.gov ID
- NCT01944748
- Acronym / sponsor ID
- R34DA031910
- Conditions
- Family Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Sep 2013 (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 goal of this project is to conduct a pilot evaluation of a parent-child mediation program for at-risk youth. It is investigating whether families who receive parent-child mediation show greater improvement in family functioning, as well as adolescent substance use, academic performance, and delinquency, over a 6-week and 12-week period compared to a wait-list control sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Mediation | Experimental | Behavioral: Families Able To Resolve Situations (FARS)Families receive FARS family mediation program after completing baseline survey. |
| Wait-list control | No intervention | –Families receive FARS family mediation program after completing baseline, 6-week and 12-week surveys. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Has a child referred to FARS due to having problems in any of the following areas: (a) poor grades; (b) truancy; (c) defiant behavior; (d) running away; (e) delinquency; (f) substance use
- Agrees to participate in at least one FARS mediation session
- Agrees to complete 3 surveys and be available over the next 3 months for follow-up
- Fluent in English or Spanish
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Families Able To Resolve Situations (FARS)Family mediation is a method of resolving conflicts between parents and teens. During the mediation session, the parent and teen each meet one-on-one with a trained volunteer mediator, who is a neutral person who listens to each party's concerns without taking sides. Then the parent and teen come together and meet with this mediator to work on resolving conflicts they are having. Families participate in up to 3 mediation sessions. | Behavioural | Family Mediation |
Primary outcome
Positive Family Relations
Time frame: 6-week
6-item Positive Family Relations measure adapted from the Cohesion subscale of Moos \& Moos Family Environment Scale (Metzler et al., 1998; Journal of Family Psychology, 12, 600-619). Items are rated on a 5-point scale ("not at all" to "very much") and averaged to create a scale score.
Family Conflict
Time frame: 6-week
5-item measure from the Family, Friends and Self (FFS) assessment scales (Simpson \& McBride, 1992; Hispanic Journal of Behavioral Sciences, 14, 327-340). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Family Communication
Time frame: 6-week
10-item measure assessing open vs. problem communication (McCubbin, Thompson \& McCubbin, 1996; Family assessment: Resiliency, coping and adaptation - Inventories for research and practice. Madison, WI: University of Wisconsin). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Parent Support
Time frame: 6-week
4-item measure (Wills et al., 2004; Psychology of Addictive Behaviors, 18, 122-134). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Positive Family Relations
Time frame: 12-week
6-item Positive Family Relations measure adapted from the Cohesion subscale of Moos \& Moos Family Environment Scale (Metzler et al., 1998; Journal of Family Psychology, 12, 600-619). Items are rated on a 5-point scale ("not at all" to "very much") and averaged to create a scale score.
Family Conflict
Time frame: 12-week
5-item measure from the Family, Friends and Self (FFS) assessment scales (Simpson \& McBride, 1992; Hispanic Journal of Behavioral Sciences, 14, 327-340). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Family Communication
Time frame: 12-week
10-item measure assessing open vs. problem communication (McCubbin, Thompson \& McCubbin, 1996; Family assessment: Resiliency, coping and adaptation - Inventories for research and practice. Madison, WI: University of Wisconsin). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
Parent Support
Time frame: 12-week
4-item measure (Wills et al., 2004; Psychology of Addictive Behaviors, 18, 122-134). Items are rated on a 5-point scale ("never" to "almost always") and averaged to create a scale score.
6 secondary outcomes
Lifetime and Past Month Substance Use
Time frame: 6-week
Academic Performance
Time frame: 6-week
Delinquency
Time frame: 6-weeks
Lifetime and Past Month Substance Use
Time frame: 12-week
Academic Performance
Time frame: 12-week
Delinquency
Time frame: 12-weeks
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 6 Apr 2016.
Related trials for Family Functioning
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Smart Sock for Monitoring Walking and Supporting Physical Activity in Older Adults: A Family-Supported Feasibility Study
Walking Mesh
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 1
Low-Dose Sirolimus for the Treatment of RUNX1 Familial Platelet Disorder
Familial Platelet Disorder With Associated Myeloid Malignancy
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.
Joan S. Tucker, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families Able To Resolve Situations (FARS) in people with Family Functioning, run by RAND 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 7 inclusion and 0 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 6 Apr 2016. 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?
Positive Family Relations (time frame: 6-week). The study lists 8 primary outcomes in all. 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 6 Apr 2016.