Adolescent - Emotional ProblemNCT03443206
Loves Company: Combatting Emotional Disturbance in the Digital Age
A study testing anonymous social support, psychoeducation and online resources in people with Adolescent - Emotional Problem, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent - Emotional Problem
- What is being tested?
- anonymous social support, psychoeducation and online resources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 14-17
- Access to internet-connected device
- Residing in the United States
Who cannot join
- Inability to assent due to intellectual disability or lack of English language skills
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Adolescent - Emotional Problem
- Being tested
- anonymous social support, psychoeducation, online resources
- Keywords
- adolescent, mental health, social media
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anonymous social supportOther
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).
psychoeducationOther
educational materials related to mental health
online resourcesOther
links to online mental health resources
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This condition will include access to a website that includes a social component, in addition to psychoeducation and access to resources. Receives: Other: anonymous social support; Other: psychoeducation; Other: online resources |
| Control | Active comparator | This condition will include access to a website that includes psychoeducation and access to resources. Receives: Other: psychoeducation; Other: online resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Suicidal Ideation Measure score
frequency of suicidal thoughts and behaviors
Measured: 6 months
Perceived burdensomeness and hopelessness scale score
lower burdensomeness and hopelessness in treatment group (lower score better)
Measured: 6 months
General Behavior Inventory 10D (GBI 10D)
symptoms of depression lower in treatment group (lower score)
Measured: 6 months
Life Satisfaction
level of satisfaction with quality of life
Measured: 6 months
Secondary outcomes (4)
Adolescent Suicidal Ideation Measure score
frequency of suicidal thoughts and behaviors
Measured: 12 months
Perceived burdensomeness and hopelessness scale score
lower burdensomeness and hopelessness in treatment group (lower score better)
Measured: 12 months
General Behavior Inventory 10D (GBI 10D)
symptoms of depression lower in treatment group (lower score)
Measured: 12 months
Life Satisfaction
level of satisfaction with quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start20 Jun 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation
- Responsible party
- Principal investigator, Anna Van Meter, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443206
- Sponsor's protocol ID
- 18-0062-ZHH
- Status last verified
- Apr 2022
- First submitted
- 2 Feb 2018
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26001665Bearman 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.
PubMed 14713704Belfer 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.
PubMed 18221350Birnbaum 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.
PubMed 25200743Brissette 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.
PubMed 11811628Gould 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.
PubMed 15322416Heflinger 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.
PubMed 20232133La 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.
PubMed 15677280Maher 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.
PubMed 24550083McGorry 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.
PubMed 23288499Safer DJ. Self-reported suicide attempts by adolescents. Ann Clin Psychiatry. 1997 Dec;9(4):263-9. doi: 10.1023/a:1022364629060.
PubMed 9511952
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loves Company: Combatting Emotional Disturbance in the Digital Age
- ClinicalTrials.gov ID
- NCT03443206
- Acronym / sponsor ID
- 18-0062-ZHH
- Conditions
- Adolescent - Emotional Problem
- Keywords
- adolescent, mental health, social media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- American Psychological Foundation
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: anonymous social support, Other: psychoeducation, Other: online resourcesThis condition will include access to a website that includes a social component, in addition to psychoeducation and access to resources. |
| Control | Active comparator | Other: psychoeducation, Other: online resourcesThis condition will include access to a website that includes psychoeducation and access to resources. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 14-17
- Access to internet-connected device
- Residing in the United States
Key exclusion criteria (1 listed)
- Inability to assent due to intellectual disability or lack of English language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anonymous social supportParticipants 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 | Intervention |
| psychoeducationeducational materials related to mental health | Other | Control, Intervention |
| online resourceslinks to online mental health resources | Other | Control, Intervention |
Primary outcome
Adolescent Suicidal Ideation Measure score
Time frame: 6 months
frequency of suicidal thoughts and behaviors
Perceived burdensomeness and hopelessness scale score
Time frame: 6 months
lower burdensomeness and hopelessness in treatment group (lower score better)
General Behavior Inventory 10D (GBI 10D)
Time frame: 6 months
symptoms of depression lower in treatment group (lower score)
Life Satisfaction
Time frame: 6 months
level of satisfaction with quality of life
4 secondary outcomes
Adolescent Suicidal Ideation Measure score
Time frame: 12 months
Perceived burdensomeness and hopelessness scale score
Time frame: 12 months
General Behavior Inventory 10D (GBI 10D)
Time frame: 12 months
Life Satisfaction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Results publication: PubMed 26001665Barzilay 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 publication: PubMed 14713704Bearman 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 publication: PubMed 18221350Belfer 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 publication: PubMed 25200743Birnbaum 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 publication: PubMed 11811628Brissette 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 publication: PubMed 15322416Gould 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 publication: PubMed 20232133Heflinger 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 publication: PubMed 15677280La 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 publication: PubMed 24550083Maher 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 publication: PubMed 23288499McGorry 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 publication: PubMed 9511952Safer DJ. Self-reported suicide attempts by adolescents. Ann Clin Psychiatry. 1997 Dec;9(4):263-9. doi: 10.1023/a:1022364629060.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anonymous social support, psychoeducation and online resources in people with Adolescent - Emotional Problem, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Suicidal Ideation Measure score (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443206, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.