DepressionNCT05407051
Family-Centered Treatment for Depression in Hispanic Youth
A study testing Family Centered Treatment and Treatment as Usual in people with Depression and Family Research, run by MetroHealth Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Family Research, Teen Depression
- What is being tested?
- Family Centered Treatment and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 31 Oct 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Adults unable to consent
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Effects of Family-Centered Treatment for Depression in Primary Care for Hispanic Youth
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.
- Conditions
- Depression, Family Research, Teen Depression
- Being tested
- Family Centered Treatment, Treatment as Usual
- Keywords
- teen depression, hispanic, family centered
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Centered TreatmentBehavioural
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.
Treatment as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | In the Treatment as Usual condition, parents will simply be given a list of mental health referrals and crisis numbers. Receives: Behavioral: Treatment as Usual |
| Family Centered Treatment | Experimental | 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. Receives: Behavioral: Family Centered Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9
Measure of Depression - score ranges from 0-27 with higher scores indicating more symptoms of depression
Measured: baseline, 3 and 6 month change
Change in Generalized Anxiety Disorder-7
Measure of Anxiety - score range from 0-21 with higher score indicating more symptoms of anxiety
Measured: baseline, 3 and 6 month change
Secondary outcomes (2)
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
Measured: baseline, 3 and 6 month change
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.
Measured: baseline, 3 and 6 month change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start30 Sep 2022
- Primary completion30 Apr 2024
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brittany Myers, PhD, Principal investigator, MetroHealth Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407051
- Sponsor's protocol ID
- STUDY00000028
- Status last verified
- Jul 2024
- First submitted
- 25 May 2022
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20431464Friedman 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.
PubMed 29089007Pilowsky 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.
PubMed 18558646Youth Risk Behavior Survey-Data Summary & Trends Report: 2007-2017. (2020). 91.
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.
PubMed 32907569Cook 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.
PubMed 18048553Kroenke 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.
PubMed 11556941Spitzer 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.
PubMed 16717171Miles 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.
PubMed 18720394Haskett 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.
PubMed 16597226
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Effects of Family-Centered Treatment for Depression in Primary Care for Hispanic Youth
- ClinicalTrials.gov ID
- NCT05407051
- Acronym / sponsor ID
- STUDY00000028
- Conditions
- Depression, Family Research, Teen Depression
- Keywords
- teen depression, hispanic, family centered
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 7 Jun 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualIn the Treatment as Usual condition, parents will simply be given a list of mental health referrals and crisis numbers. |
| Family Centered Treatment | Experimental | Behavioral: Family Centered TreatmentIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Adults unable to consent
- Pregnant women
- Prisoners
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 |
|---|---|---|
| Family Centered TreatmentIn 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. | Behavioural | Family Centered Treatment |
| Treatment as UsualAll 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. | Behavioural | Treatment as Usual |
Primary outcome
Change in Patient Health Questionnaire-9
Time frame: baseline, 3 and 6 month change
Measure of Depression - score ranges from 0-27 with higher scores indicating more symptoms of depression
Change in Generalized Anxiety Disorder-7
Time frame: baseline, 3 and 6 month change
Measure of Anxiety - score range from 0-21 with higher score indicating more symptoms of anxiety
2 secondary outcomes
Change in Post Traumatic Stress Disorder CheckList - for Civilians
Time frame: baseline, 3 and 6 month change
Change in Parenting Stress Index -4
Time frame: baseline, 3 and 6 month change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 20431464Slopen 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.
- Background: PubMed 29089007Friedman 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.
- Background: PubMed 18558646Pilowsky 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.
- BackgroundYouth Risk Behavior Survey-Data Summary & Trends Report: 2007-2017. (2020). 91.
- Background: PubMed 32907569Giano 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.
- Background: PubMed 18048553Cook 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 18720394Miles 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.
- Background: PubMed 16597226Haskett 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.
- Individual participant dataSharing planned: No
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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.
Brittany Myers, PhD principal investigator
MetroHealth Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Centered Treatment and Treatment as Usual in people with Depression and Family Research, run by MetroHealth Medical Center 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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?
Results are not available in the source record.
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?
Change in Patient Health Questionnaire-9 (time frame: baseline, 3 and 6 month change). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407051, which also lists 10 linked publications.
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 12 Jul 2024.