Clinical trial NCT03318666: Supporting Our Valued Adolescents Pilot Randomized Controlled Trial
Official title: A Pilot Randomized Controlled Trial of SOVA (Supporting Our Valued Adolescents), a Social Media Intervention for Adolescents With Depression and Anxiety and Their Parents to Increase Use of Mental Health Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Adolescent
Adolescent Medicine
Mental Health Services
eHealth
Online systems
Primary Health Care
Social media
Social support
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-10-24
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this pilot study is to provide preliminary findings testing the Supporting Our Valued Adolescents (SOVA) intervention, two social media sites (one for adolescents, one for parents) aiming to address negative health beliefs, knowledge about depression or anxiety, parent-adolescent communication, in a moderated online peer community, with the goal of increasing adolescent use of mental health services.

Detailed description: Although recent evidence shows integrated care models increase service use, implementing these models is resource intense. Even in primary care settings with access to services and routine screening for depression and anxiety, patient engagement is low. This can be explained by a low perceived need for services present in both adolescents and parents. Key target mechanisms which may increase service use include: (1) parents' and adolescents' health beliefs and knowledge, (2) emotional/informational support, and (3) communication about mental health with each other. The "SOVA" or "Supporting Our Valued Adolescents" intervention aims to address these key mechanisms through two moderated social media websites (one for parents, one for adolescents) which include daily blog posts, online peer to peer interactions, and discussion guides. SOVA had undergone an iterative process of design - using stakeholder-engagement and human computer interaction techniques (PCOR K12 HS 22989-1). The goal of this process was to build a usable intervention which is stakeholder-informed. Preliminary work has found that 100 adolescents/young adults with a history of depression or anxiety symptoms and parents find the SOVA websites to have good usability. The investigators will use a pilot randomized controlled trial of SOVA to refine recruitment and retention strategies, measure implementation outcomes and investigate potential mechanisms of action in depressed and/or anxious adolescents not currently engaged in treatment and their parents; and examine parent-adolescent communication factors about mental health and relationship quality in the context of a web-based intervention.

Eligibility criteria: Inclusion Criteria:

Adolescent:

* Ages 12-19
* AHCP identifies depressive and/or anxiety symptoms
* Scores at least 5 or greater on the PHQ-9 (depression) and/or GAD-7 (anxiety) consistent with at least mild symptoms
* AHCP recommends adolescent to initiate a new treatment episode (no treatment in past 3 months)
* Can read and write in English
* Have completed the 6th grade
* Assent (\<18 y/o)/Consent to study (18 or 19 y/o)

Parent:

* Adolescent child meets inclusion/exclusion criteria and agrees to enroll in the study
* Can read and write in English
* Have completed the 6th grade
* Consent to study

Adolescent Healthcare Provider:

* Healthcare provider (physician, nurse practitioner, physician assistant) providing clinical services in the Center for Adolescent and Young Adult Health
* Consents to study

Exclusion Criteria:

-

Adolescent:

* Actively suicidal requiring crisis/hospitalization defined as: currently having suicidal thoughts and a plan AND AHCP recommends immediate crisis services and/or evaluation for hospitalization
* History of receiving a psychiatric medication and/or psychotherapy for depression and/or anxiety in the past 3 months
* No access to internet
* No active email account

Parent:

* No access to internet
* No active email account

Adolescent Healthcare Provier:

• None

Primary outcomes:
measure: Study retention
timeFrame: 6 weeks
Secondary outcomes:
measure: Intervention acceptability
timeFrame: at study completion, an average of 1year
measure: Health beliefs: Stigma
timeFrame: 6 weeks
measure: Health Beliefs: Beliefs about Antidepressants - Resistance
timeFrame: 6 weeks
measure: Health Beliefs: Beliefs about Antidepressants - Meanings
timeFrame: 6 weeks
measure: Health Beliefs: Beliefs About Therapy - Adolescents
timeFrame: 6 weeks
measure: Health Beliefs: Beliefs About Therapy - Parents
timeFrame: 6 weeks
measure: Depression Knowledge
timeFrame: 6 weeks
measure: Anxiety Knowledge
timeFrame: 6 weeks
measure: Peer emotional/informational support
timeFrame: 6 weeks
measure: Peer social support
timeFrame: 6 weeks
measure: Parent-Adolescent Communication Quality-Parent Form-Openness Subscale
timeFrame: 6 weeks
measure: Parent-Adolescent Communication Quality-Parent Form-Extent of Problems Subscale
timeFrame: 6 weeks
measure: Parent-Adolescent Communication Quality-Adolescent Form-Openness Subscale
timeFrame: 6 weeks
measure: Parent-Adolescent Communication Quality-Adolescent Form-Extent of Problems Subscale
timeFrame: 6 weeks
measure: Perceived Need for Treatment - Open ended question
timeFrame: 6 weeks
measure: Perceived Need for Treatment - Survey Measure
timeFrame: 6 weeks
measure: Actual Receipt of Mental Health Services
timeFrame: 6 weeks and 3 months
measure: Depressive Symptoms
timeFrame: 6 weeks
measure: Anxiety Symptoms
timeFrame: 6 weeks
measure: Functioning
timeFrame: 6 weeks
measure: Relationship Quality
timeFrame: 6 weeks
measure: Adolescent Help Seeking - Adolescent Perception
timeFrame: 6 weeks
measure: Adolescent Help Seeking - Parent Perception of Adolescent Help Seeking
timeFrame: 6 weeks
measure: Parent Help Seeking (for Parent themselves)
timeFrame: 6 weeks
measure: Parent perception of Adolescent Functioning
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Center for Adolescent and Young Adult Health
state: Pennsylvania
Study officials:
References:
citation: Radovic A, DeMand AL, Gmelin T, Stein BD, Miller E. SOVA: Design of a stakeholder informed social media website for depressed adolescents and their parents. J Technol Hum Serv. 2018;35(3):169-182. doi: 10.1080/15228835.2017.1347552. Epub 2017 Jul 24.
citation: Radovic A, Li Y, Landsittel D, Stein BD, Miller E. A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents With Depression and/or Anxiety and Their Parents: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 23;8(1):e12117. doi: 10.2196/12117.
citation: Radovic A, Odenthal K, Flores AT, Miller E, Stein BD. Prescribing Technology to Increase Uptake of Depression Treatment in Primary Care: A Pre-implementation Focus Group Study of SOVA (Supporting Our Valued Adolescents). J Clin Psychol Med Settings. 2020 Dec;27(4):766-782. doi: 10.1007/s10880-019-09669-5.
citation: Radovic A, Li Y, Landsittel D, Odenthal KR, Stein BD, Miller E. A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents With Depression or Anxiety: Pilot Randomized Controlled Trial. JMIR Ment Health. 2022 Oct 7;9(10):e35313. doi: 10.2196/35313.