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Integrated Treatment for Youth With Mood Disorders

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ClinicalTrials.gov Identifier: NCT03800303
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jarrod M. Leffler, Ph.D., L.P., Mayo Clinic

Brief 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. evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.

Condition or disease Intervention/treatment Phase
Mood Disorders in Children and Adolescents Behavioral: Family-based treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healthy Youth & Families: An Integrated Approach to Treating Mood Disorders
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

Arm Intervention/treatment
Experimental: two-week family-based treatment
Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design.
Behavioral: Family-based treatment
2-week family-based treatment




Primary Outcome Measures :
  1. Conner's Comprehensive Behavior Rating Scales [ Time Frame: 12 months ]
    Likert scale items measuring symptom presentation



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800303


Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Jarrod Leffler, PhD    507-293-2557    leffler.jarrod@mayo.edu   
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jarrod Leffler, PhD    507-293-2557    leffler.jarrod@mayo.edu   
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jarrod Leffler, PhD    507-293-2557    leffler.jarrod@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jarrod M Leffler Mayo Clinic

Responsible Party: Jarrod M. Leffler, Ph.D., L.P., Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03800303     History of Changes
Other Study ID Numbers: 17-010831
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jarrod M. Leffler, Ph.D., L.P., Mayo Clinic:
depression
bipolar
caregivers
children
adolescents
treatment
parents

Additional relevant MeSH terms:
Disease
Mood Disorders
Pathologic Processes
Mental Disorders