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
About this trial
This is an interventional supportive care trial for Adolescent - Emotional Problem focused on measuring adolescent, mental health, social media
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
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
NCT ID
NCT03443206
First Posted
February 2, 2018
Last Updated
April 8, 2022
Sponsor
Northwell Health
Collaborators
American Psychological Foundation
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:
PubMed Identifier
26001665
Citation
Barzilay S, Feldman D, Snir A, Apter A, Carli V, Hoven CW, Wasserman C, Sarchiapone M, Wasserman D. The interpersonal theory of suicide and adolescent suicidal behavior. J Affect Disord. 2015 Sep 1;183:68-74. doi: 10.1016/j.jad.2015.04.047. Epub 2015 May 7.
Results Reference
result
PubMed Identifier
14713704
Citation
Bearman PS, Moody J. Suicide and friendships among American adolescents. Am J Public Health. 2004 Jan;94(1):89-95. doi: 10.2105/ajph.94.1.89.
Results Reference
result
PubMed Identifier
18221350
Citation
Belfer ML. Child and adolescent mental disorders: the magnitude of the problem across the globe. J Child Psychol Psychiatry. 2008 Mar;49(3):226-36. doi: 10.1111/j.1469-7610.2007.01855.x. Epub 2008 Jan 21.
Results Reference
result
PubMed Identifier
25200743
Citation
Birnbaum ML, Candan K, Libby I, Pascucci O, Kane J. Impact of online resources and social media on help-seeking behaviour in youth with psychotic symptoms. Early Interv Psychiatry. 2016 Oct;10(5):397-403. doi: 10.1111/eip.12179. Epub 2014 Sep 9.
Results Reference
result
PubMed Identifier
11811628
Citation
Brissette I, Scheier MF, Carver CS. The role of optimism in social network development, coping, and psychological adjustment during a life transition. J Pers Soc Psychol. 2002 Jan;82(1):102-11. doi: 10.1037//0022-3514.82.1.102.
Results Reference
result
PubMed Identifier
15322416
Citation
Gould MS, Velting D, Kleinman M, Lucas C, Thomas JG, Chung M. Teenagers' attitudes about coping strategies and help-seeking behavior for suicidality. J Am Acad Child Adolesc Psychiatry. 2004 Sep;43(9):1124-33. doi: 10.1097/01.chi.0000132811.06547.31.
Results Reference
result
PubMed Identifier
20232133
Citation
Heflinger CA, Hinshaw SP. Stigma in child and adolescent mental health services research: understanding professional and institutional stigmatization of youth with mental health problems and their families. Adm Policy Ment Health. 2010 Mar;37(1-2):61-70. doi: 10.1007/s10488-010-0294-z.
Results Reference
result
PubMed Identifier
15677280
Citation
La Greca AM, Harrison HM. Adolescent peer relations, friendships, and romantic relationships: do they predict social anxiety and depression? J Clin Child Adolesc Psychol. 2005 Mar;34(1):49-61. doi: 10.1207/s15374424jccp3401_5.
Results Reference
result
PubMed Identifier
24550083
Citation
Maher CA, Lewis LK, Ferrar K, Marshall S, De Bourdeaudhuij I, Vandelanotte C. Are health behavior change interventions that use online social networks effective? A systematic review. J Med Internet Res. 2014 Feb 14;16(2):e40. doi: 10.2196/jmir.2952.
Results Reference
result
PubMed Identifier
23288499
Citation
McGorry P, Bates T, Birchwood M. Designing youth mental health services for the 21st century: examples from Australia, Ireland and the UK. Br J Psychiatry Suppl. 2013 Jan;54:s30-5. doi: 10.1192/bjp.bp.112.119214.
Results Reference
result
PubMed Identifier
9511952
Citation
Safer DJ. Self-reported suicide attempts by adolescents. Ann Clin Psychiatry. 1997 Dec;9(4):263-9. doi: 10.1023/a:1022364629060.
Results Reference
result
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Loves Company: Combatting Emotional Disturbance in the Digital Age
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