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Clinical Trials/NCT04030897
NCT04030897
Unknown
Not Applicable

Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths

Stony Brook University1 site in 1 country246 target enrollmentJanuary 15, 2020
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Stony Brook University
Enrollment
246
Locations
1
Primary Endpoint
Mental Health Treatment-Seeking Behavior Checklist
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2020
End Date
August 30, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Schleider

Assistant Professor of Psychology

Stony Brook University

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

Outcomes

Primary Outcomes

Mental Health Treatment-Seeking Behavior Checklist

Time Frame: Baseline to 3-month follow-up

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.'

Change in Children's Depression Inventory 2 - Youth Report Total Score

Time Frame: Baseline to 3-month follow-up.

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.

Secondary Outcomes

  • Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)(Baseline to 3-month follow-up.)
  • 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 Attitudes Toward Therapy Scale - Parent(Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).)
  • Mental Health Treatment Access at 3-month follow-up(3-month follow-up)
  • 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).)
  • Change in Barriers to Accessing Care Evaluation (BACE)(Baseline to 3-month follow-up)
  • Change in Perceived Stress Scale(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 Brief Symptom Inventory - 18(Baseline to 3-month follow-up)
  • Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score(Baseline to 3-month follow-up.)
  • Change in Children's Depression Inventory 2 - Parent Report total score(Baseline to 3-month follow-up.)

Study Sites (1)

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