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Promoting Treatment Access Following Pediatric Primary Care Depression Screening

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04030897
Enrollment
246
Registered
2019-07-24
Start date
2020-01-15
Completion date
2021-08-30
Last updated
2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

BEHAVIORALParent-Directed Online Single-Session Program

Online, 15-minute self-administered program for parents

BEHAVIORALYouth-Directed Online Single-Session Program

Online, 30 minute self-administered program for youths

BEHAVIORALInformation/Psychoeducation/Referral

Usual care at pediatric primary care clinics participating in this study

Sponsors

The Klingenstein Third Generation Foundation
CollaboratorOTHER
Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, 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.

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.

Eligibility

Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mental Health Treatment-Seeking Behavior ChecklistBaseline to 3-month follow-upAt 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 ScoreBaseline 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

MeasureTime frameDescription
Change in Pediatric Symptom Checklist- Parent Report Total scoreBaseline 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)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)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)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 - 18Baseline to 3-month follow-upThe 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 Attitudes Toward Therapy Scale - ParentBaseline 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-up3-month follow-upParents 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 ScaleBaseline to 3-month follow-upThe 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 ScoreBaseline 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 Children's Depression Inventory 2 - Parent Report total scoreBaseline to 3-month follow-up.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.
Change in Barriers to Accessing Care Evaluation (BACE)Baseline to 3-month follow-upParents 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 Pediatric Symptom Checklist - Youth-Report Total scoreBaseline 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.

Other

MeasureTime frameDescription
Change in implicit theories of emotion scale, parent-reportBaseline 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-reportBaseline 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).

Countries

United States

Contacts

Primary ContactJessica L Schleider
jessica.schleider@stonybrook.edu631-632-4131

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026