Supporting Our Valued Adolescents Pilot Randomized Controlled Trial

NCT ID: NCT03318666

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2020-04-06

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Enhanced Usual Care (EUC)

Both arms will receive this intervention

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: OTHER

A social worker at the Center for Adolescent and Young Adult Health (CAYAH) clinic helps to facilitate referrals from the adolescent healthcare provider (AHCP) and contacts patients who do not schedule for within-CAYAH appointments.The study will send an extra email to the parent and adolescent that contains the content of the depart summary as well as a list of psychoeducational materials, how to contact the AHCP, CAYAH social worker, and crisis resources and the AHCP's treatment recommendation which are obtained from the electronic health record. Also, each individual will receive a phone call from a research assistant who will communicate the information in the email and offer to inform the social worker or AHCP of questions the patient or parent may have.

Supporting Our Valued Adolescents (SOVA)

This arm will receive the SOVA intervention in addition to Enhanced Usual Care

Group Type: EXPERIMENTAL

Supporting Our Valued Adolescents (SOVA)

Intervention Type: BEHAVIORAL

The SOVA intervention includes:

• a welcome email to the websites (adolescents also get a SOVA intro video and mobile app)
• adolescents will have access to the website specifically for adolescents: sova.pitt.edu
• parents will have access to the website specifically for parents: wisesova.pitt.edu

These anonymous websites aim to: (1) challenge negative health beliefs and increase depression/anxiety knowledge through daily blog posts enhanced with peer commentary; (2) promote social support through online peer interactions; and (3) encourage parent-adolescent mental health communication through same day blog posts with questions for discussion. Parents and adolescents cannot log on to each other's sites. The sites are moderated by our research team.

The SOVA websites include articles composed by SOVA Peer Ambassadors who are adolescents and young adults who have experienced symptoms of depression or anxiety and contribute monthly articles and regular comments.

Enhanced Usual Care

Intervention Type: OTHER

A social worker at the Center for Adolescent and Young Adult Health (CAYAH) clinic helps to facilitate referrals from the adolescent healthcare provider (AHCP) and contacts patients who do not schedule for within-CAYAH appointments.The study will send an extra email to the parent and adolescent that contains the content of the depart summary as well as a list of psychoeducational materials, how to contact the AHCP, CAYAH social worker, and crisis resources and the AHCP's treatment recommendation which are obtained from the electronic health record. Also, each individual will receive a phone call from a research assistant who will communicate the information in the email and offer to inform the social worker or AHCP of questions the patient or parent may have.

Interventions

Supporting Our Valued Adolescents (SOVA)

The SOVA intervention includes:

• a welcome email to the websites (adolescents also get a SOVA intro video and mobile app)
• adolescents will have access to the website specifically for adolescents: sova.pitt.edu
• parents will have access to the website specifically for parents: wisesova.pitt.edu

These anonymous websites aim to: (1) challenge negative health beliefs and increase depression/anxiety knowledge through daily blog posts enhanced with peer commentary; (2) promote social support through online peer interactions; and (3) encourage parent-adolescent mental health communication through same day blog posts with questions for discussion. Parents and adolescents cannot log on to each other's sites. The sites are moderated by our research team.

The SOVA websites include articles composed by SOVA Peer Ambassadors who are adolescents and young adults who have experienced symptoms of depression or anxiety and contribute monthly articles and regular comments.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

A social worker at the Center for Adolescent and Young Adult Health (CAYAH) clinic helps to facilitate referrals from the adolescent healthcare provider (AHCP) and contacts patients who do not schedule for within-CAYAH appointments.The study will send an extra email to the parent and adolescent that contains the content of the depart summary as well as a list of psychoeducational materials, how to contact the AHCP, CAYAH social worker, and crisis resources and the AHCP's treatment recommendation which are obtained from the electronic health record. Also, each individual will receive a phone call from a research assistant who will communicate the information in the email and offer to inform the social worker or AHCP of questions the patient or parent may have.

Intervention Type: OTHER

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:

Exclusion Criteria

• 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

-

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Ana Radovic

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Adolescent and Young Adult Health

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29743822 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30672741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31630347 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36206044 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23MH111922-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO17070601

Identifier Type: -

Identifier Source: org_study_id