Mood Disorders in Children and AdolescentsNCT03800303
Integrated Treatment for Youth With Mood Disorders
A study testing Family-based treatment in people with Mood Disorders in Children and Adolescents, run by Mayo Clinic at 3 sites in United States.
Trial summary
In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to: 1. evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity); 2. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Mood Disorders in Children and Adolescents
- What is being tested?
- Family-based treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Mar 2018to 31 Dec 2019
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents between the ages of 10 and 18 years;
- Diagnosed with a primary depressive or bipolar disorder;
- Admitted to the Child and Adolescent Integrated Mood Program (CAIMP) at Mayo Clinic.
Who cannot join
- Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Healthy Youth & Families: An Integrated Approach to Treating Mood Disorders
In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to:
- evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity);
- evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.
- Being tested
- Family-based treatment
- Keywords
- depression, bipolar, caregivers, children, adolescents, treatment, parents
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based treatmentBehavioural
2-week family-based treatment
| Study group | Role | What they receive |
|---|---|---|
| two-week family-based treatment | Experimental | Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design. Receives: Behavioral: Family-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conner's Comprehensive Behavior Rating Scales
Likert scale items measuring symptom presentation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start15 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood Disorders in Children and AdolescentsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jarrod M. Leffler, Ph.D., L.P., Mayo Clinic
- Investigators
- Jarrod M Leffler, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800303
- Sponsor's protocol ID
- 17-010831
- Status last verified
- Dec 2020
- First submitted
- 15 Mar 2018
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Youth & Families: An Integrated Approach to Treating Mood Disorders
- ClinicalTrials.gov ID
- NCT03800303
- Acronym / sponsor ID
- 17-010831
- Keywords
- depression, bipolar, caregivers, children, adolescents, treatment, parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jan 2019 (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.
In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to:
- evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity);
- evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| two-week family-based treatment | Experimental | Behavioral: Family-based treatmentActive treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children and adolescents between the ages of 10 and 18 years;
- Diagnosed with a primary depressive or bipolar disorder;
- Admitted to the Child and Adolescent Integrated Mood Program (CAIMP) at Mayo Clinic.
Key exclusion criteria (1 listed)
- Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic.
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-based treatment2-week family-based treatment | Behavioural | two-week family-based treatment |
Primary outcome
Conner's Comprehensive Behavior Rating Scales
Time frame: 12 months
Likert scale items measuring symptom presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Jarrod M Leffler principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based treatment in people with Mood Disorders in Children and Adolescents, run by Mayo Clinic at 3 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Conner's Comprehensive Behavior Rating Scales (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2020.