Clinical trial NCT04558489: Bridging the Gap to Improve Mental Health Treatment Utilization
Official title: Bridging the Gap: Utility of a Single Session Intervention to Change Attitudes Toward Treatment, and Improve Acceptance of Further Psychotherapy for Depressed and/or Anxious Youth and Their Caretakers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Anxiety
Adolescent Behavior
Suicidal Ideation
Keywords: depression
pediatric primary care
adolescent behavior
mood disorder
technology
provider
intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2020-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will use an open trial design, where all participants will receive the Growth Mindset Intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Bridging the Gap aims to improve access to effective mental health treatment in a primary care setting through utilization of single session growth mindset interventions for parents and for youths. This project will also utilize focus groups and qualitative interviews to gain feedback on a single session online intervention in a rural pediatric primary care practice.

Detailed description: Bridging the Gap purposes to collect feedback on a single session growth mindset intervention (GMI) for parents and for youths designed to instill beliefs that personal traits (including mental health problems) are malleable. Feedback will also be collected to identify ways to improve implementing single session interventions (SSIs) in a primary care setting as well as identifying the impact on work-flow of this GMI. Patients presenting with depression and/or anxiety will all receive the GMI and will have the option of participating in focus groups/interviews pre and post-intervention to provide feedback on the intervention. Providers at this rural pediatric primary care practice will also have the chance to participate in focus groups/interviews pre and post-intervention implementation.

Assignment of Interventions: As an open trial, all participants will be assigned to the intervention arm and will receive the GMI.

This study is an open trial pilot project to collect feedback on a single session growth mindset intervention (GMI) (n=25 youth/caretaker dyads). Feedback from pre and post-intervention focus groups/interviews will be collected for 8 parents, 8 youth, and 8 treatment providers.

The aims of the study are to:

1. Collect feedback from providers, parents, and participants pre and post- GMI to identify ways to improve implementing single session interventions (SSIs) in a primary care setting.
2. Identify the impact on work-flow of using an online single session called Growth Mindset Intervention in a primary care setting.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with depression and/or anxiety, as identified by the patient, parent, or provider
* 10-18 years old
* CBT is recommended by provider. Receipt of mental health services upon enrollment will be monitored but will not preclude participation
* Participants must reside with a legal guardian
* English speaking

Exclusion Criteria:

* Participants will be excluded if they have conditions that might impair their ability to effectively engage in Bridging the Gap, i.e
* Those in a current manic episode
* Those in a current psychotic episode
* Those diagnosed with Autism Spectrum Disorder
* Those who have issues with substance abuse
* Participants with current involvement with child welfare.

Primary outcomes:
measure: Change from baseline in child and parental attitudes towards therapy at 4 weeks
timeFrame: Baseline vs. 4 week follow-up
measure: Change from baseline in view of emotions as changeable at 4 weeks
timeFrame: Baseline vs. 4 week follow-up
measure: Change from baseline in view of personality as changeable at 4 weeks
timeFrame: Baseline vs. 4 week follow-up
measure: Hopelessness
timeFrame: Up to 4 weeks after baseline
Secondary outcomes:
measure: Anxiety Severity
timeFrame: Up to 4 weeks after baseline
measure: Depression Severity
timeFrame: Up to 4 weeks after baseline
measure: Psychological distress
timeFrame: Up to 4 weeks after baseline
Other outcomes:
Locations:
city: Kittanning
country: United States
facility: Children's Community Pediatrics (CCP- Armstrong Kittanning) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Tina Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: David Brent, MD
role: STUDY_DIRECTOR
References: