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Promoting Treatment Access Following Pediatric Primary Care Depression Screening

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-Directed Online Single-Session Program
Youth-Directed Online Single-Session Program
Information/Psychoeducation/Referral
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stony Brook UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Online Programs + Information/Psychoeducation/Referral (IPR)

Information/Psychoeducation/Referral (IPR; usual care control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.'
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.

Secondary Outcome Measures

Change in Pediatric Symptom Checklist - Youth-Report Total score
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.
Change in Pediatric Symptom Checklist- Parent Report Total score
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.
Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)
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.
Change in Beck Hopelessness Scale - 4 (Youth Report)
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.
Change in Beck Hopelessness Scale - 4 (Parent Report)
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.
Change in Brief Symptom Inventory - 18
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.
Change in Barriers to Accessing Care Evaluation (BACE)
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.
Change in Attitudes Toward Therapy Scale - Parent
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.
Mental Health Treatment Access at 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).
Change in Perceived Stress Scale
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.
Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score
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.
Change in Children's Depression Inventory 2 - Parent Report total score
Parent reported youth depressive symptoms, total score derived from 17-item parent-report version of CDI-2. Scores range from 0-54, and higher scores indicate greater youth depression severity.

Full Information

First Posted
July 20, 2019
Last Updated
March 5, 2020
Sponsor
Stony Brook University
Collaborators
The Klingenstein Third Generation Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04030897
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
The Klingenstein Third Generation Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online Programs + Information/Psychoeducation/Referral (IPR)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Information/Psychoeducation/Referral (IPR; usual care control)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent-Directed Online Single-Session Program
Intervention Description
Online, 15-minute self-administered program for parents
Intervention Type
Behavioral
Intervention Name(s)
Youth-Directed Online Single-Session Program
Other Intervention Name(s)
Project Personality
Intervention Description
Online, 30 minute self-administered program for youths
Intervention Type
Behavioral
Intervention Name(s)
Information/Psychoeducation/Referral
Intervention Description
Usual care at pediatric primary care clinics participating in this study
Primary Outcome Measure Information:
Title
Mental Health Treatment-Seeking Behavior Checklist
Description
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.'
Time Frame
Baseline to 3-month follow-up
Title
Change in Children's Depression Inventory 2 - Youth Report Total Score
Description
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.
Time Frame
Baseline to 3-month follow-up.
Secondary Outcome Measure Information:
Title
Change in Pediatric Symptom Checklist - Youth-Report Total score
Description
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.
Time Frame
Baseline to 3-month follow-up.
Title
Change in Pediatric Symptom Checklist- Parent Report Total score
Description
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.
Time Frame
Baseline to 3-month follow-up.
Title
Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)
Description
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.
Time Frame
Baseline to 3-month follow-up.
Title
Change in Beck Hopelessness Scale - 4 (Youth Report)
Description
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.
Time Frame
Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Title
Change in Beck Hopelessness Scale - 4 (Parent Report)
Description
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.
Time Frame
Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Title
Change in Brief Symptom Inventory - 18
Description
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.
Time Frame
Baseline to 3-month follow-up
Title
Change in Barriers to Accessing Care Evaluation (BACE)
Description
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.
Time Frame
Baseline to 3-month follow-up
Title
Change in Attitudes Toward Therapy Scale - Parent
Description
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.
Time Frame
Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Title
Mental Health Treatment Access at 3-month follow-up
Description
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).
Time Frame
3-month follow-up
Title
Change in Perceived Stress Scale
Description
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.
Time Frame
Baseline to 3-month follow-up
Title
Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score
Description
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.
Time Frame
Baseline to 3-month follow-up.
Title
Change in Children's Depression Inventory 2 - Parent Report total score
Description
Parent reported youth depressive symptoms, total score derived from 17-item parent-report version of CDI-2. Scores range from 0-54, and higher scores indicate greater youth depression severity.
Time Frame
Baseline to 3-month follow-up.
Other Pre-specified Outcome Measures:
Title
Change in implicit theories of emotion scale, parent-report
Description
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-).
Time Frame
Baseline to immediate-post-online intervention (active intervention group only)
Title
Change in Implicit Theories of Personality Questionnaire, youth-report
Description
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).
Time Frame
Baseline to immediate-post-online intervention (active intervention group only)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica L Schleider
Phone
631-632-4131
Email
jessica.schleider@stonybrook.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Schleider, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-2500
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica L Schleider, PhD
Phone
631-632-4131
Email
jessica.schleider@stonybrook.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).
IPD Sharing Time Frame
Study protocol and a statistical analysis plan have been uploaded with this pre-registration.
IPD Sharing 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)
Citations:
PubMed Identifier
32666919
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. Erratum In: J Am Acad Child Adolesc Psychiatry. 2020 Dec;59(12):1408-1410.
Results Reference
derived

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Promoting Treatment Access Following Pediatric Primary Care Depression Screening

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