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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01944748
Other study ID # R34DA031910
Secondary ID
Status Completed
Phase N/A
First received September 3, 2013
Last updated April 5, 2016
Start date July 2011
Est. completion date April 2016

Study information

Verified date April 2016
Source RAND
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
Study type Interventional

Clinical 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 6-week and 12-week period compared to a wait-list control sample.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date April 2016
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 19 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Centinela Youth Services Hawthorne California

Sponsors (1)

Lead Sponsor Collaborator
RAND

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6-week No
Primary 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. 6-week No
Primary 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. 6-week No
Primary 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. 6-week No
Primary 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. 12-week No
Primary 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. 12-week No
Primary 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. 12-week No
Primary 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. 12-week No
Secondary 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").
6-week No
Secondary 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. 6-week No
Secondary 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"). 6-weeks No
Secondary 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").
12-week No
Secondary 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. 12-week No
Secondary 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"). 12-weeks No
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