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Loves Company: Combatting Emotional Disturbance in the Digital Age

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ClinicalTrials.gov Identifier: NCT03443206
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
American Psychological Foundation
Information provided by (Responsible Party):
Anna Van Meter, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Adolescent - Emotional Problem Other: anonymous social support Other: psychoeducation Other: online resources Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Loves Company: Combatting Emotional Disturbance in the Digital Age
Estimated Study Start Date : August 20, 2019
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : August 20, 2020

Arm Intervention/treatment
Experimental: Intervention
This condition will include access to a website that includes a social component, in addition to psychoeducation and access to resources.
Other: anonymous social support
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).

Other: psychoeducation
educational materials related to mental health

Other: online resources
links to online mental health resources

Active Comparator: Control
This condition will include access to a website that includes psychoeducation and access to resources.
Other: psychoeducation
educational materials related to mental health

Other: online resources
links to online mental health resources




Primary Outcome Measures :
  1. Adolescent Suicidal Ideation Measure score [ Time Frame: 6 months ]
    frequency of suicidal thoughts and behaviors

  2. Perceived burdensomeness and hopelessness scale score [ Time Frame: 6 months ]
    lower burdensomeness and hopelessness in treatment group (lower score better)

  3. General Behavior Inventory 10D (GBI 10D) [ Time Frame: 6 months ]
    symptoms of depression lower in treatment group (lower score)

  4. Life Satisfaction [ Time Frame: 6 months ]
    level of satisfaction with quality of life


Secondary Outcome Measures :
  1. Adolescent Suicidal Ideation Measure score [ Time Frame: 12 months ]
    frequency of suicidal thoughts and behaviors

  2. Perceived burdensomeness and hopelessness scale score [ Time Frame: 12 months ]
    lower burdensomeness and hopelessness in treatment group (lower score better)

  3. General Behavior Inventory 10D (GBI 10D) [ Time Frame: 12 months ]
    symptoms of depression lower in treatment group (lower score)

  4. Life Satisfaction [ Time Frame: 12 months ]
    level of satisfaction with quality of life


Other Outcome Measures:
  1. site engagement [ Time Frame: 6 months ]
    time spent on site

  2. General Behavior Inventory 10D (GBI 10D) [ Time Frame: weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 ]
    changes in depressive symptoms

  3. Perceived burdensomeness and hopelessness scale score [ Time Frame: weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 ]
    change in burdensomeness and hopelessness



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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


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): NCT03443206


Contacts
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Contact: Anna Van Meter, PhD 718-470-5813 avanmeter@northwell.edu

Sponsors and Collaborators
Northwell Health
American Psychological Foundation

Publications of Results:

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Responsible Party: Anna Van Meter, Assistant Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT03443206     History of Changes
Other Study ID Numbers: 18-0062-ZHH
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Anna Van Meter, Northwell Health:
adolescent
mental health
social media

Additional relevant MeSH terms:
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Affective Symptoms
Behavioral Symptoms