NCT03800303

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. 1.evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity);
  2. 2.evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

March 15, 2018

Last Update Submit

December 28, 2020

Conditions

Mood Disorders in Children and Adolescents

Keywords

depressionbipolarcaregiverschildrenadolescentstreatmentparents

Outcome Measures

Primary Outcomes (1)

  • Conner's Comprehensive Behavior Rating Scales

    Likert scale items measuring symptom presentation

    12 months

Study Arms (1)

two-week family-based treatment

EXPERIMENTAL

Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design.

Behavioral: Family-based treatment

Interventions

Family-based treatmentBEHAVIORAL

2-week family-based treatment

two-week family-based treatment

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jarrod M Leffler

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2018

First Posted

January 11, 2019

Study Start

March 15, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations

US(3)