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Promoting Treatment Access Following Pediatric Primary Care Depression Screening

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ClinicalTrials.gov Identifier: NCT04030897
Recruitment Status : Not yet recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
The Klingenstein Third Generation Foundation
Information provided by (Responsible Party):
Jessica Schleider, Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Parent-Directed Online Single-Session Program Behavioral: Youth-Directed Online Single-Session Program Behavioral: Information/Psychoeducation/Referral Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Parent-Directed Online Single-Session Program
Online, 15-minute self-administered program for parents

Behavioral: Youth-Directed Online Single-Session Program
Online, 30 minute self-administered program for youths
Other Name: Project Personality

Behavioral: Information/Psychoeducation/Referral
Usual care at pediatric primary care clinics participating in this study

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.
Behavioral: Information/Psychoeducation/Referral
Usual care at pediatric primary care clinics participating in this study




Primary Outcome Measures :
  1. 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.'

  2. Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score [ Time Frame: Baseline to 3-month follow-up. ]
    Youth-report measure of youth depressive symptoms. Youth rate 5 items reflecting internalizing symptoms on a scale from 0-2. Total scores range from 0 to 10. Higher scores indicate higher internalizing symptom severity.


Secondary Outcome Measures :
  1. Change in Pediatric Symptom Checklist - Youth-Report Total score [ Time Frame: Baseline to 3-month follow-up. ]
    Youth-report measure of overall youth psychopathology. Youth rate 35 items on a 0-2 scale reflecting internalizing, externalizing, and attention-related symptoms. Scores range from 0 - 70. Higher scores indicate higher overall symptom severity.

  2. Change in Pediatric Symptom Checklist- Parent Report Total score [ Time Frame: Baseline to 3-month follow-up. ]
    Youth-report measure of overall youth psychopathology. Youth rate 35 items on a 0-2 scale reflecting internalizing, externalizing, and attention-related symptoms. Scores range from 0 - 70. Higher scores indicate higher overall symptom severity.

  3. Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report) [ Time Frame: Baseline to 3-month follow-up. ]
    Parent-report measure of overall youth psychopathology. Parents rate 5 items on a 0-2 scale reflecting internalizing symptoms in their child. Scores range from 0-10. Higher scores indicate higher overall symptom severity.

  4. Change in Beck Hopelessness Scale - 4 (Youth Report) [ Time Frame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups). ]
    Respondents (youths) report agreement with 4 items indicating levels of hopelessness about the future. Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12.

  5. Change in Beck Hopelessness Scale - 4 (Parent Report) [ Time Frame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups). ]
    Respondents (parents) report agreement with 4 items indicating levels of hopelessness about the future. Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12.

  6. Change in Brief Symptom Inventory - 18 [ Time Frame: Baseline to 3-month follow-up ]
    The Brief Symptom Inventory-18 (BSI-18) assesses self reported parent psychopathology and distress. Adult respondents rate endorsement of 18 physical and emotional complaints on a 0-4 Likert scale. The total sum score yields an additional total distress score (range: 0-72). Higher scores indicate higher levels of overall psychological distress.

  7. Change in Barriers to Accessing Care Evaluation (BACE) [ Time Frame: Baseline to 3-month follow-up ]
    Parents rate the 30 items on a 0-3 scale indicating the degree to which various beliefs, concerns, circumstances, and logistical difficulties have stopped, delayed or discouraged them from getting professional care for their child's mental health problem. Higher total scores indicate greater perceived barriers to care. Scores range from 0-90, with higher scores indicating more overall barriers to accessing mental health care for their child.

  8. Change in Attitudes Toward Therapy Scale - Parent [ Time Frame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups). ]
    One-item measure used to assess parents' perceptions that therapy/counseling would be useful in reducing their child's emotional or behavioral difficulties, rated on a 0-10 scale (total score range: 0-10). Higher scores indicate stronger beliefs that therapy may help reduce mental health problems, whereas lower scores indicate weaker beliefs that therapy may help reduce mental health problems.

  9. Mental Health Treatment Access at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Parents will indicate (yes/no) whether their child has received (a) new and/or (b) continuing school-based, outpatient, or other mental health-related services since the child's recent PC appointment (at baseline) and since the baseline assessment (at 3-month follow-up).

  10. Change in Perceived Stress Scale [ Time Frame: Baseline to 3-month follow-up ]
    The PSS is a well-validated measure of the degree to which situations in one's life are appraised as stressful, unpredictable, and uncontrollable. Higher total scores indicate greater overall perceived stress. The scale includes 10 items rated on a 0-4 scales, and scores range from 0-40.


Other Outcome Measures:
  1. Change in implicit theories of emotion scale, parent-report [ Time Frame: Baseline to immediate-post-online intervention (active intervention group only) ]
    This measure will be used as a manipulation check for parents assigned to the active intervention condition. Parents will be asked to report the degree to which they view emotions as malleable (versus immutable) at pre- and post-intervention using a previously validated, 4-item assessment of emotion mindsets in adults. Four items are rated using a 1-to-6 Likert scale. Higher mean scores on these items indicate a stronger fixed emotion mindset, a lower scores, a stronger growth emotion mindset (range: 1-).

  2. Change in Implicit Theories of Personality Questionnaire, youth-report [ Time Frame: Baseline to immediate-post-online intervention (active intervention group only) ]
    This measure will be used as a manipulation check for youths assigned to the active intervention condition. Respondents rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-6 Likert scale (e.g. "Your personality is something about you that you can't change very much"). Higher mean scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset (range: 1-6).



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030897


Contacts
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Contact: Jessica L Schleider 631-632-4131 jessica.schleider@stonybrook.edu

Locations
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United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794-2500
Sponsors and Collaborators
Stony Brook University
The Klingenstein Third Generation Foundation
Investigators
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Principal Investigator: Jessica Schleider, PhD Stony Brook University
  Study Documents (Full-Text)

Documents provided by Jessica Schleider, Stony Brook University:

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Responsible Party: Jessica Schleider, Assistant Professor of Psychology, Stony Brook University
ClinicalTrials.gov Identifier: NCT04030897     History of Changes
Other Study ID Numbers: IRB2019-00241
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual-level participant data will be made publicly available on Open Science Framework upon completion of the grant period (August 2021).
Supporting Materials: Study Protocol
Statistical Analysis Plan (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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders