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Loves Company: Combatting Emotional Disturbance in the Digital Age

Primary Purpose

Adolescent - Emotional Problem

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
anonymous social support
psychoeducation
online resources
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adolescent - Emotional Problem focused on measuring adolescent, mental health, social media

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 14-17
  • Access to internet-connected device
  • Residing in the United States

Exclusion Criteria:

*Inability to assent due to intellectual disability or lack of English language skills

Sites / Locations

  • Northwell Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

This condition will include access to a website that includes a social component, in addition to psychoeducation and access to resources.

This condition will include access to a website that includes psychoeducation and access to resources.

Outcomes

Primary Outcome Measures

Adolescent Suicidal Ideation Measure score
frequency of suicidal thoughts and behaviors
Perceived burdensomeness and hopelessness scale score
lower burdensomeness and hopelessness in treatment group (lower score better)
General Behavior Inventory 10D (GBI 10D)
symptoms of depression lower in treatment group (lower score)
Life Satisfaction
level of satisfaction with quality of life

Secondary Outcome Measures

Adolescent Suicidal Ideation Measure score
frequency of suicidal thoughts and behaviors
Perceived burdensomeness and hopelessness scale score
lower burdensomeness and hopelessness in treatment group (lower score better)
General Behavior Inventory 10D (GBI 10D)
symptoms of depression lower in treatment group (lower score)
Life Satisfaction
level of satisfaction with quality of life

Full Information

First Posted
February 2, 2018
Last Updated
April 8, 2022
Sponsor
Northwell Health
Collaborators
American Psychological Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03443206
Brief Title
Loves Company: Combatting Emotional Disturbance in the Digital Age
Official Title
Loves Company: Combatting Emotional Disturbance in the Digital Age
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
American Psychological Foundation

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
The goal of this study is to determine whether a community-based website that is intended to provide support for adolescents experiencing psychological distress can improve members' mental health outcomes. The investigators want to understand if a digital platform can help young people who are suffering and may be unlikely to access more traditional forms of mental health services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent - Emotional Problem
Keywords
adolescent, mental health, social media

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This condition will include access to a website that includes a social component, in addition to psychoeducation and access to resources.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This condition will include access to a website that includes psychoeducation and access to resources.
Intervention Type
Other
Intervention Name(s)
anonymous social support
Intervention Description
Participants randomized to the intervention condition will be able to communicate with one another and offer social media-based forms of support (e.g., post music, photos, etc).
Intervention Type
Other
Intervention Name(s)
psychoeducation
Intervention Description
educational materials related to mental health
Intervention Type
Other
Intervention Name(s)
online resources
Intervention Description
links to online mental health resources
Primary Outcome Measure Information:
Title
Adolescent Suicidal Ideation Measure score
Description
frequency of suicidal thoughts and behaviors
Time Frame
6 months
Title
Perceived burdensomeness and hopelessness scale score
Description
lower burdensomeness and hopelessness in treatment group (lower score better)
Time Frame
6 months
Title
General Behavior Inventory 10D (GBI 10D)
Description
symptoms of depression lower in treatment group (lower score)
Time Frame
6 months
Title
Life Satisfaction
Description
level of satisfaction with quality of life
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adolescent Suicidal Ideation Measure score
Description
frequency of suicidal thoughts and behaviors
Time Frame
12 months
Title
Perceived burdensomeness and hopelessness scale score
Description
lower burdensomeness and hopelessness in treatment group (lower score better)
Time Frame
12 months
Title
General Behavior Inventory 10D (GBI 10D)
Description
symptoms of depression lower in treatment group (lower score)
Time Frame
12 months
Title
Life Satisfaction
Description
level of satisfaction with quality of life
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
site engagement
Description
time spent on site
Time Frame
6 months
Title
General Behavior Inventory 10D (GBI 10D)
Description
changes in depressive symptoms
Time Frame
weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Title
Perceived burdensomeness and hopelessness scale score
Description
change in burdensomeness and hopelessness
Time Frame
weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 14-17 Access to internet-connected device Residing in the United States Exclusion Criteria: *Inability to assent due to intellectual disability or lack of English language skills
Facility Information:
Facility Name
Northwell Health
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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26001665
Citation
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Loves Company: Combatting Emotional Disturbance in the Digital Age

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