FOCUS:Families OverComing Under Stress

Completed · Not applicable

Conditions studied: Cancer, Depression, PostTraumatic Stress Disorder, Anxiety

In brief

The FOCUS program (study treatment) is an established evidence-based intervention whose redesign for families and couples dealing with serious and chronic illnesses will provide a creative and promising supplement to the existing support services at Cedars-Sinai Medical Center. All participants will receive the 10-weeks of 75-minute weekly study treatment, but will be split into two groups, the immediate treatment group and the wait list treatment group, who will receive the study treatment after the immediate 10 weeks of treatment is completed.

Key facts

Study ID

NCT02992405

Run by

Cedars-Sinai Medical Center

People needed

32

Starts

2016-12-05

Expected to finish

2018-05-18

Last updated by the study team

2019-02-07

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Written informed consent will be obtained from each participating adult subject and written assent from each minor participating in the program. Specific criteria for inclusion into the program are as follows:
• Couples must have at least one partner and families at least one parent who is or has been diagnosed with cancer at least 30 days prior to study start and not more than one year from last treatment visit.
• Couples or parents must be at least 18 years old and must be English speakers.
• At least one member of the couple must score >60 on the Anxiety or Depression scale on the Brief Symptom Index 18 administered during the screening visit and/or have notable difficulties in relationship or family functioning, as resulted in a ≥2 score in FAD subscale or at least one RDAS subscale question answered 'more often than not' or more frequent.
• The families participating in the study must have at least one child older than the age of five.
• Participating families must have at least one parent who can provide legal consent for the participation of their child(ren) in the program.
• Participants must be willing and able to complete 10 sessions within 14 weeks.
• Participants undergoing active management or care plans for abuse or psychopathology may enroll in study if reports of ongoing management are provided.

You may not qualify if…

• There must not be any participant with urgent and/or immediate health needs (where a possible 10-week wait time poses more than minimal risks).
• There must not be active (within the last 30 days and/or during study intervention) and unmanaged domestic violence or abuse, substance abuse, or extreme forms of psychopathology such as psychosis that would interfere with the treatment.
• Primary presenting personal and/or relational issues are largely unrelated to the cancer diagnosis and treatment, as determined by the screening clinician.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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