Clinical trial NCT04030897: Promoting Treatment Access Following Pediatric Primary Care Depression Screening
Official title: Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: The Klingenstein Third Generation Foundation
First posted: 2019-07-24
Enrollment: 246
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mental Health Treatment-Seeking Behavior Checklist
timeFrame: Baseline to 3-month follow-up
measure: Change in Children's Depression Inventory 2 - Youth Report Total Score
timeFrame: Baseline to 3-month follow-up.
Secondary outcomes:
measure: Change in Pediatric Symptom Checklist - Youth-Report Total score
timeFrame: Baseline to 3-month follow-up.
measure: Change in Pediatric Symptom Checklist- Parent Report Total score
timeFrame: Baseline to 3-month follow-up.
measure: Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)
timeFrame: Baseline to 3-month follow-up.
measure: Change in Beck Hopelessness Scale - 4 (Youth Report)
timeFrame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
measure: Change in Beck Hopelessness Scale - 4 (Parent Report)
timeFrame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
measure: Change in Brief Symptom Inventory - 18
timeFrame: Baseline to 3-month follow-up
measure: Change in Barriers to Accessing Care Evaluation (BACE)
timeFrame: Baseline to 3-month follow-up
measure: Change in Attitudes Toward Therapy Scale - Parent
timeFrame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
measure: Mental Health Treatment Access at 3-month follow-up
timeFrame: 3-month follow-up
measure: Change in Perceived Stress Scale
timeFrame: Baseline to 3-month follow-up
measure: Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score
timeFrame: Baseline to 3-month follow-up.
measure: Change in Children's Depression Inventory 2 - Parent Report total score
timeFrame: Baseline to 3-month follow-up.
Other outcomes:
measure: Change in implicit theories of emotion scale, parent-report
timeFrame: Baseline to immediate-post-online intervention (active intervention group only)
measure: Change in Implicit Theories of Personality Questionnaire, youth-report
timeFrame: Baseline to immediate-post-online intervention (active intervention group only)
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Jessica Schleider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.