Promoting Treatment Access Following Pediatric Primary Care Depression Screening

NCT ID: NCT04030897

Last Updated: 2020-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Youths reporting elevated MD symptoms at a PC visit (N = 200) will be randomly assigned to one of two conditions (within a waitlist-control design): Information, Psychoeducation, and Referral (IPR; ie., usual care, or the "control") or IPR enhanced with youth- and parent-directed online SSIs (IPR+SSI), designed to reduce youth MD symptoms and improve parents' expectancies of mental health treatment, respectively.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
Participating youths and parents will be aware of whether they are receiving the online interventions immediately or after the 3-month follow-up period (i.e., whether they are in the 'intervention group' or the 'waitlist group'). However, participating families will be assigned to these conditions via an online survey, which they complete remotely, and condition assignments will be unknown to the research team and the youth's primary care provider.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Parent-Directed Online Single-Session Program

Intervention Type BEHAVIORAL

Online, 15-minute self-administered program for parents

Youth-Directed Online Single-Session Program

Intervention Type BEHAVIORAL

Online, 30 minute self-administered program for youths

Information/Psychoeducation/Referral

Intervention Type BEHAVIORAL

Usual care at pediatric primary care clinics participating in this study

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.

Group Type PLACEBO_COMPARATOR

Information/Psychoeducation/Referral

Intervention Type BEHAVIORAL

Usual care at pediatric primary care clinics participating in this study

Interventions

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Parent-Directed Online Single-Session Program

Online, 15-minute self-administered program for parents

Intervention Type BEHAVIORAL

Youth-Directed Online Single-Session Program

Online, 30 minute self-administered program for youths

Intervention Type BEHAVIORAL

Information/Psychoeducation/Referral

Usual care at pediatric primary care clinics participating in this study

Intervention Type BEHAVIORAL

Other Intervention Names

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Project Personality

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Klingenstein Third Generation Foundation

OTHER

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Schleider

Assistant Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Schleider, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook University

Stony Brook, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica L Schleider

Role: CONTACT

631-632-4131

Facility Contacts

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Jessica L Schleider, PhD

Role: primary

631-632-4131

References

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Schleider JL, Dobias M, Fassler J, Shroff A, Pati S. Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Randomized Trial of Web-Based, Single-Session Interventions for Parents and Youths. J Am Acad Child Adolesc Psychiatry. 2020 Jun;59(6):770-773. doi: 10.1016/j.jaac.2020.01.025. Epub 2020 Apr 28. No abstract available.

Reference Type DERIVED
PMID: 32666919 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB2019-00241

Identifier Type: -

Identifier Source: org_study_id

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