Promoting Treatment Access Following Pediatric Primary Care Depression Screening
1 other identifier
interventional
246
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedMarch 6, 2020
March 1, 2020
1.3 years
July 20, 2019
March 5, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Mental Health Treatment-Seeking Behavior Checklist
At baseline and 3-month follow-up, parents will indicate whether they have engaged in each of four treatment-seeking behaviors for their child: researched local mental healthcare providers/agencies for their child; contacted a mental healthcare provider or agency about treatment for their child; contacted child's school regarding mental health supports for their child; and scheduled an appointment OR placed child on a waiting-list with a mental healthcare provider/agency. Total number of treatment-seeking behaviors between baseline and 3-month follow-up may range from 0 to 4. Individual behaviors are self-reported by parents on as 'yes' or 'no' (noting whether they engaged in the behavior during the study period). At baseline, parents will report on whether they engaged in these behaviors 'since the child's last doctor's appointment.' At follow-up, parents will report whether they have engaged in these behaviors 'since their past survey, 3 months ago.'
Baseline to 3-month follow-up
Change in Children's Depression Inventory 2 - Youth Report Total Score
Change in youth reported depressive symptoms, total score derived from 28-item CDI-2. Scores range from 0-56, with higher scores indicating higher levels of depression.
Baseline to 3-month follow-up.
Secondary Outcomes (12)
Change in Pediatric Symptom Checklist - Youth-Report Total score
Baseline to 3-month follow-up.
Change in Pediatric Symptom Checklist- Parent Report Total score
Baseline to 3-month follow-up.
Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)
Baseline to 3-month follow-up.
Change in Beck Hopelessness Scale - 4 (Youth Report)
Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Change in Beck Hopelessness Scale - 4 (Parent Report)
Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
- +7 more secondary outcomes
Other Outcomes (2)
Change in implicit theories of emotion scale, parent-report
Baseline to immediate-post-online intervention (active intervention group only)
Change in Implicit Theories of Personality Questionnaire, youth-report
Baseline to immediate-post-online intervention (active intervention group only)
Study Arms (2)
Online Programs + Information/Psychoeducation/Referral (IPR)
ACTIVE COMPARATORIncludes 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.
Information/Psychoeducation/Referral (IPR; usual care control)
PLACEBO COMPARATORInformation, 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
Online, 15-minute self-administered program for parents
Online, 30 minute self-administered program for youths
Usual care at pediatric primary care clinics participating in this study
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Parent or youth is not comfortable reading and/or writing in English
- Parent or youth is not comfortable with online activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook University
Stony Brook, New York, 11794-2500, United States
Related Publications (1)
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.
PMID: 32666919DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Schleider, PhD
Stony Brook University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychology
Study Record Dates
First Submitted
July 20, 2019
First Posted
July 24, 2019
Study Start
January 15, 2020
Primary Completion
April 30, 2021
Study Completion
August 30, 2021
Last Updated
March 6, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Study protocol and a statistical analysis plan have been uploaded with this pre-registration.
- Access Criteria
- Materials will be publicly available on clinicaltrials.gov. IPD will be made publicly available on Open Science Framework upon completion of the grant period (August 2021)
De-identified individual-level participant data will be made publicly available on Open Science Framework upon completion of the grant period (August 2021).