Recruiting

GM-SSI & IPR

Sponsor:

Stony Brook University

Code:

NCT04030897

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 11 - 16

Healthy Volunteers: Not accepted

Interventions

Parent-Directed Online Single-Session Program

Youth-Directed Online Single-Session Program

Information/Psychoeducation/Referral

Study Details

Brief summary:

Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs; GM-SSIs have also improved parents' expectancies that psychotherapy could benefit their children's mental health. This project will test whether these online, youth- and parent-directed GM-SSIs-designed to reduce youth depressive symptoms and improve parents' mental health treatment expectancies, respectively-may increase mental health service access, reduce youth depressive symptoms, and relieve parental stress following PC-based youth MD screening. Youths reporting elevated MD symptoms at PC visits (N = 200) will receive either Information/Psychoeducation/Referral (IPR) or IPR plus parent- and youth-directed GM-SSIs (IPR+SSI). The investigators will examine whether IPR+SSI, versus IPR alone, increases MD service access; reduces parental stress; and reduces youth depressive symptoms across three months. Results may yield a disseminable model for promoting youth treatment access after PC-based depression screening.

Conditions

Depression

Study ID

NCT04030897

Start date

Jan 15, 2020

Status verified date

Mar, 2020

Completion date

Aug 30, 2021

Anticipated

Primary completion date

Apr 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Youth is between the ages of 11 and 16, inclusive, at the time of study recruitment
  • Youth reports a Pediatric Symptom Checklist 'Internalizing' score of 5 or higher (out of 10) at her/his most recent pediatric primary care visit at 1 of the 9 Stony Brook University-affiliated clinics participating in this study
  • Parent and youth are comfortable with reading and writing in English
  • Parent and youth are comfortable with online activity

Exclusion Criteria:

  • Parent or youth is not comfortable reading and/or writing in English
  • Parent or youth is not comfortable with online activity

Study Design

Enrollment

246 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Online Programs + Information/Psychoeducation/Referral (IPR)

Includes 2 online, one-session programs (one for youths; one for parents) and Primary Care-based IPR. The 30-min, self-administered YOUTH PROGRAM includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change. In the 15-min Qualtrics-based PARENT PROGRAM, parents read 2 scientific passages on (1) the notion that emotions are flexible in youth and adults, and (2) that failure promotes personal growth. After each passage, parents write a persuasive summary of its main arguments, directed to fellow parents who may benefit from the information.

placebo comparator: Information/Psychoeducation/Referral (IPR; usual care control)

Information, Psychoeducation and Referral (IPR) represents usual care in the Stony Brook University Hospital's Pediatric Primary Care Division. Families of a youth with elevated MD symptoms during a PC visit receive a folder containing informational materials about the nature of depression and referrals to providers in their area. All families in this study will receive PC-based IPR.

Interventions

Parent-Directed Online Single-Session Program

Online, 15-minute self-administered program for parents

Youth-Directed Online Single-Session Program

Online, 30 minute self-administered program for youths

Information/Psychoeducation/Referral

Usual care at pediatric primary care clinics participating in this study

Primary outcome measure

  • Mental Health Treatment-Seeking Behavior Checklist [ Time Frame: Baseline to 3-month follow-up ]
  • Change in Children's Depression Inventory 2 - Youth Report Total Score [ Time Frame: Baseline to 3-month follow-up. ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794-2500

Contacts

More Information

Sponsor

Stony Brook University

Last update posted

Mar 6, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2020-03-06.