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Family-Centered Treatment for Depression in Hispanic Youth

Primary Purpose

Depression, Family Research, Teen Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Centered Treatment
Treatment as Usual
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring teen depression, hispanic, family centered

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Teens 12+ seen in pediatric Hispanic clinic will be screened using the Patient Health Questionnaire -9 for depression as a part of standard clinic protocols. Parents of teens 12+ who screen positive for depression who also screen positive for mental health concerns may be included in the study. Parents who participate in the initial survey but who do NOT screen positive for any of their own mental health concerns will be given a list of mental health referrals and crisis numbers but will not be eligible to participate in the rest of the study or any follow-up calls.

Parents or legal guardians may be included in the study if their teen is over the age of 12, being seen in the pediatric Hispanic clinic, screens positive for depression during pediatric visit, and if parents then screen positive for any mental health concern during the initial survey.

Exclusion Criteria:

  • Adults unable to consent
  • Pregnant women
  • Prisoners

Sites / Locations

  • MetroHealth Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual

Family Centered Treatment

Arm Description

In the Treatment as Usual condition, parents will simply be given a list of mental health referrals and crisis numbers.

In the Family-Centered Treatment Arm, parents would be given the same list of mental health referrals and crisis numbers, but in this condition, they would authorize researchers to share their contact information with the partner agency, Catholic Charities, and would then be linked directly to bilingual adult mental health services there with a behavioral health provider who would provide collateral therapy to parents via telehealth. Although parents will be referred to the community partner for therapy as a part of the research intervention, the behavioral health providers at the community partner will be providing therapy as they usually do for these participants in line with their usual job duties.

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire-9
Measure of Depression - score ranges from 0-27 with higher scores indicating more symptoms of depression
Change in Generalized Anxiety Disorder-7
Measure of Anxiety - score range from 0-21 with higher score indicating more symptoms of anxiety

Secondary Outcome Measures

Change in Post Traumatic Stress Disorder CheckList - for Civilians
Measure of Post Traumatic Stress disorder -score ranges from 17-85 with higher scores indicating more symptoms of Post Traumatic Stress
Change in Parenting Stress Index -4
Parenting stress index - raw scores are calculated and converted to percentiles with specified cutoffs for each subscale. Higher percentiles indicate higher levels of parenting stress.

Full Information

First Posted
May 25, 2022
Last Updated
August 17, 2023
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05407051
Brief Title
Family-Centered Treatment for Depression in Hispanic Youth
Official Title
Investigating Effects of Family-Centered Treatment for Depression in Primary Care for Hispanic Youth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Studies suggest that for youth in poverty, addressing stressors like parental mental health concerns may improve children's mental health outcomes. Rates of depression and suicidality are growing among teens nationwide and rates of depression are disproportionately high for Hispanic youth. Hispanic families are disproportionately impacted by poverty and are disproportionately exposed to adverse childhood experiences, yet Hispanic patients are less likely than non-Hispanic patient to have access to specialty mental healthcare. Integrating mental health care into primary care is one avenue towards making specialized mental healthcare more accessible to the Hispanic community. There have been few studies focused on addressing parental mental health within pediatric primary care, and even fewer focused specifically on supporting Hispanic families within primary care. The current study would seek to formally assess whether a family-centered treatment approach improves depression outcomes for both Hispanic teens and parents identified in primary care. The current study would implement depression screening for teens and global mental health screening for parents in MetroHealth's Pediatric Hispanic Clinic. Teens identified with depression would receive integrated consultation with a psychology provider as usual. In this study, parents who agree to participate would also be screened for depression, anxiety, trauma and parenting stress. Parents who screen positive would then be randomized to receive either a list of referrals for bilingual mental health services in the community (treatment as usual), or into the family-centered treatment arm. In the family-centered treatment arm, parents would be connected directly to bilingual adult mental health services with a community partner, Catholic Charities, who would provide collateral therapy to parents via telehealth. Families will then receive follow-up calls from a bilingual MetroHealth provider 3- and 6-months later to re-administer the same parent outcome measures. Investigators hypothesize that adolescent depression symptoms will improve to a greater degree in the family-centered treatment condition as compared to treatment as usual, and that measures of parental mental health and parenting stress will show significantly greater improvement in the family-centered treatment condition as compared to treatment as usual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Family Research, Teen Depression
Keywords
teen depression, hispanic, family centered

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
In the Treatment as Usual condition, parents will simply be given a list of mental health referrals and crisis numbers.
Arm Title
Family Centered Treatment
Arm Type
Experimental
Arm Description
In the Family-Centered Treatment Arm, parents would be given the same list of mental health referrals and crisis numbers, but in this condition, they would authorize researchers to share their contact information with the partner agency, Catholic Charities, and would then be linked directly to bilingual adult mental health services there with a behavioral health provider who would provide collateral therapy to parents via telehealth. Although parents will be referred to the community partner for therapy as a part of the research intervention, the behavioral health providers at the community partner will be providing therapy as they usually do for these participants in line with their usual job duties.
Intervention Type
Behavioral
Intervention Name(s)
Family Centered Treatment
Intervention Description
In the Family-Centered Treatment Arm, parents would be given the same list of mental health referrals and crisis numbers, but in this condition, they would authorize researchers to share their contact information with the partner agency, Catholic Charities, and would then be linked directly to bilingual adult mental health services there with a behavioral health provider who would provide collateral therapy to parents via telehealth. Although parents will be referred to the community partner for therapy as a part of the research intervention, the behavioral health providers at the community partner will be providing therapy as they usually do for these participants in line with their usual job duties.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
All participants (parents) would receive follow-up calls from a MetroHealth research personnel at 3 months and 6 months to measure changes in parent mental health outcomes, as well as satisfaction. Children of parents in both conditions will receive treatment as usual which includes brief consultation for 3-5 sessions with an integrated MetroHealth behavioral health provider which is already standard practice in the clinic. Sessions typically occur monthly. Teens will be re-administered the Patient Health Questionnaire -9 by the integrated behavioral health provider as a part of clinical practice to measure treatment progress and this information will be obtained at the end of 6 months of treatment via chart review (see data sheet). Repeated measurement of patient's symptoms over the course of several months of treatment is common in clinical practice to measure patient's symptom improvement.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9
Description
Measure of Depression - score ranges from 0-27 with higher scores indicating more symptoms of depression
Time Frame
baseline, 3 and 6 month change
Title
Change in Generalized Anxiety Disorder-7
Description
Measure of Anxiety - score range from 0-21 with higher score indicating more symptoms of anxiety
Time Frame
baseline, 3 and 6 month change
Secondary Outcome Measure Information:
Title
Change in Post Traumatic Stress Disorder CheckList - for Civilians
Description
Measure of Post Traumatic Stress disorder -score ranges from 17-85 with higher scores indicating more symptoms of Post Traumatic Stress
Time Frame
baseline, 3 and 6 month change
Title
Change in Parenting Stress Index -4
Description
Parenting stress index - raw scores are calculated and converted to percentiles with specified cutoffs for each subscale. Higher percentiles indicate higher levels of parenting stress.
Time Frame
baseline, 3 and 6 month change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Teens 12+ seen in pediatric Hispanic clinic will be screened using the Patient Health Questionnaire -9 for depression as a part of standard clinic protocols. Parents of teens 12+ who screen positive for depression who also screen positive for mental health concerns may be included in the study. Parents who participate in the initial survey but who do NOT screen positive for any of their own mental health concerns will be given a list of mental health referrals and crisis numbers but will not be eligible to participate in the rest of the study or any follow-up calls. Parents or legal guardians may be included in the study if their teen is over the age of 12, being seen in the pediatric Hispanic clinic, screens positive for depression during pediatric visit, and if parents then screen positive for any mental health concern during the initial survey. Exclusion Criteria: Adults unable to consent Pregnant women Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Myers, PhD
Phone
216-778-1622
Email
bmyers1@metrohealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline Dolata, MBA
Phone
2167781792
Email
jdolata@metrohealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittany Myers, PhD
Organizational Affiliation
MetroHealth Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Dolata, MBA
Phone
216-778-1792
Email
jdolata@metrohealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20431464
Citation
Slopen N, Fitzmaurice G, Williams DR, Gilman SE. Poverty, food insecurity, and the behavior for childhood internalizing and externalizing disorders. J Am Acad Child Adolesc Psychiatry. 2010 May;49(5):444-52. doi: 10.1097/00004583-201005000-00005.
Results Reference
background
PubMed Identifier
29089007
Citation
Friedman SH, McEwan MV. Treated Mental Illness and the Risk of Child Abuse Perpetration. Psychiatr Serv. 2018 Feb 1;69(2):211-216. doi: 10.1176/appi.ps.201700120. Epub 2017 Nov 1.
Results Reference
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PubMed Identifier
18558646
Citation
Pilowsky DJ, Wickramaratne P, Talati A, Tang M, Hughes CW, Garber J, Malloy E, King C, Cerda G, Sood AB, Alpert JE, Trivedi MH, Fava M, Rush AJ, Wisniewski S, Weissman MM. Children of depressed mothers 1 year after the initiation of maternal treatment: findings from the STAR*D-Child Study. Am J Psychiatry. 2008 Sep;165(9):1136-47. doi: 10.1176/appi.ajp.2008.07081286. Epub 2008 Jun 16.
Results Reference
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Citation
Youth Risk Behavior Survey-Data Summary & Trends Report: 2007-2017. (2020). 91.
Results Reference
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PubMed Identifier
32907569
Citation
Giano Z, Wheeler DL, Hubach RD. The frequencies and disparities of adverse childhood experiences in the U.S. BMC Public Health. 2020 Sep 10;20(1):1327. doi: 10.1186/s12889-020-09411-z.
Results Reference
background
PubMed Identifier
18048553
Citation
Cook BL, McGuire T, Miranda J. Measuring trends in mental health care disparities, 2000 2004. Psychiatr Serv. 2007 Dec;58(12):1533-40. doi: 10.1176/ps.2007.58.12.1533.
Results Reference
background
PubMed Identifier
11556941
Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
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PubMed Identifier
16717171
Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Results Reference
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PubMed Identifier
18720394
Citation
Miles JN, Marshall GN, Schell TL. Spanish and English versions of the PTSD Checklist-Civilian version (PCL-C): testing for differential item functioning. J Trauma Stress. 2008 Aug;21(4):369-76. doi: 10.1002/jts.20349.
Results Reference
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PubMed Identifier
16597226
Citation
Haskett ME, Ahern LS, Ward CS, Allaire JC. Factor structure and validity of the parenting stress index-short form. J Clin Child Adolesc Psychol. 2006 Jun;35(2):302-12. doi: 10.1207/s15374424jccp3502_14. Erratum In: J Clin Child Adolesc Psychol. 2017 Jan-Feb;46(1):170.
Results Reference
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Family-Centered Treatment for Depression in Hispanic Youth

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