Promoting Treatment Access Following Pediatric Primary Care Depression Screening
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04030897|
Recruitment Status : Not yet recruiting
First Posted : July 24, 2019
Last Update Posted : September 18, 2019
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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.|
|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 :||October 15, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||August 30, 2021|
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
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.
Usual care at pediatric primary care clinics participating in this study
- 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 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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-).
- 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).
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
|Contact: Jessica L Schleiderfirstname.lastname@example.org|
|United States, New York|
|Stony Brook University|
|Stony Brook, New York, United States, 11794-2500|
|Principal Investigator:||Jessica Schleider, PhD||Stony Brook University|