Back to resultsIntegrated Treatment for Youth With Mood Disorders
Primary Purpose
Mood Disorders in Children and Adolescents
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based treatment
Sponsored by
About this trial
This is an interventional treatment trial for Mood Disorders in Children and Adolescents focused on measuring depression, bipolar, caregivers, children, adolescents, treatment, parents
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic.
Sites / Locations
- Mayo Clinic in Arizona
- Mayo Clinic in Florida
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
two-week family-based treatment
Arm Description
Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design.
Outcomes
Primary Outcome Measures
Conner's Comprehensive Behavior Rating Scales
Likert scale items measuring symptom presentation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03800303
Brief Title
Integrated Treatment for Youth With Mood Disorders
Official Title
Healthy Youth & Families: An Integrated Approach to Treating Mood Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders in Children and Adolescents
Keywords
depression, bipolar, caregivers, children, adolescents, treatment, parents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
two-week family-based treatment
Arm Type
Experimental
Arm Description
Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design.
Intervention Type
Behavioral
Intervention Name(s)
Family-based treatment
Intervention Description
2-week family-based treatment
Primary Outcome Measure Information:
Title
Conner's Comprehensive Behavior Rating Scales
Description
Likert scale items measuring symptom presentation
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarrod M Leffler
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Integrated Treatment for Youth With Mood Disorders
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