Family Mediation Program For At-Risk Youth

April 5, 2016 updated by: RAND
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Hawthorne, California, United States, 90250
        • Centinela Youth Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Agrees to participate in at least one FARS mediation session
  3. Agrees to complete 3 surveys and be available over the next 3 months for follow-up

  4. 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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Family Mediation
Families receive FARS family mediation program after completing baseline survey.
Behavioral: 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.
No Intervention: Wait-list control
Families receive FARS family mediation program after completing baseline, 6-week and 12-week surveys.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6-week
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.
6-week
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.
6-week
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.
6-week
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.
12-week
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.
12-week
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.
12-week
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.
12-week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lifetime and Past Month Substance Use
Time Frame: 6-week

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").
6-week
Academic Performance
Time Frame: 6-week
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.
6-week
Delinquency
Time Frame: 6-weeks
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").
6-weeks
Lifetime and Past Month Substance Use
Time Frame: 12-week

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").
12-week
Academic Performance
Time Frame: 12-week
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.
12-week
Delinquency
Time Frame: 12-weeks
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").
12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RAND

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joan S. Tucker, PhD, RAND

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34DA031910 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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