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Bridging the Gap to Improve Mental Health Treatment Utilization

Primary Purpose

Depression, Anxiety, Adolescent Behavior

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPR + GMI
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring depression, pediatric primary care, adolescent behavior, mood disorder, technology, provider, intervention

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Community Pediatrics (CCP- Armstrong Kittanning) of Children's Hospital of Pittsburgh of UPMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IPR + GMI

Arm Description

Participants receiving IPR + GMI will complete a 30-minute on-line intervention via qualtrics that covers the following topics: (1) Educate youth and caregiver that thoughts and emotions are not fixed but are malleable and subject to change; (2) provide youth and families with a brief intervention that instills hopefulness through an action plan for managing internalizing symptoms; (3) assist with developing system of support to access during times of distress; and (4) educate the caregiver on the importance of these interventions.

Outcomes

Primary Outcome Measures

Change from baseline in child and parental attitudes towards therapy at 4 weeks
Child and parental attitudes towards therapy will be assessed via Attitudes Towards Therapy Scale, as the primary outcome of Bridging the Gap. Scores on this one question assessment range from 0= view of therapy as not at all helpful to 10= view of therapy as very helpful.
Change from baseline in view of emotions as changeable at 4 weeks
Child and parental views of personality as changeable will be assessed via Implicit Theory of Emotions Scale, as the primary outcome of Bridging the Gap. The Implicit Theory of Emotion contains 4 questions, with two incremental items and two entity items. Each item is rated using a 7-point Likert scale with 1= strongly disagree and 7= strongly agree. The two entity items are reverse-scored. Scores range from 4-28 and higher scores indicate a view of emotions as changeable.
Change from baseline in view of personality as changeable at 4 weeks
Child and parental views of personality as changeable will be assessed via Implicit Theory of Personality Questionnaire, as the primary outcome of Bridging the Gap. The Implicit Theory of Personality Questionnaire contains 3 questions with a range of scores from 3 to 18, with lower scores indicating a view of personality as changeable.
Hopelessness
Child and parent hopelessness will be assessed via Beck Hopelessness Short Scale, as the primary outcome of Bridging the Gap. This 4-item scale is totaled using the sum of item scores. Scores range from 0-12, with higher scores indicating more hopelessness.

Secondary Outcome Measures

Anxiety Severity
Child anxiety severity will be assessed via SCARED 5-item, as a secondary outcome of Bridging the Gap. This 5-item assessment has scores ranging from 0-10, with higher scores indicating more self-reported anxiety.
Depression Severity
Child and parent depression severity will be assessed via MFQ questionnaire, as a secondary outcome of Bridging the Gap. The MFQ Child version has scores ranging from 0-66, with a higher score indicating more severe depression. The MFQ Parent version has scores ranging from 0-69, with higher score indicating more severe depression.
Psychological distress
Child and parent psychological distress will be assessed via PHQ4 questionnaire, as a secondary outcome of Bridging the Gap. The PHQ4 contains 4 questions, 2 questions relating to depression and 2 questions relating to anxiety, with scores ranging from 0-12. Higher scores on the PHQ4 indicate more severe psychological distress.

Full Information

First Posted
September 9, 2020
Last Updated
January 6, 2022
Sponsor
University of Pittsburgh
Collaborators
Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04558489
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
This study has withdrawn due to recruitment issues at our pediatric primary care setting. Due to the COVID-19 pandemic and other unforeseen medical absences, the study was unable to recruit participants.
Study Start Date
December 30, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)

4. Oversight

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

5. Study Description

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: 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. Identify the impact on work-flow of using an online single session called Growth Mindset Intervention in a primary care setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Adolescent Behavior, Suicidal Ideation
Keywords
depression, pediatric primary care, adolescent behavior, mood disorder, technology, provider, intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will use an open trial design, where all participants will receive the Growth Mindset Intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPR + GMI
Arm Type
Experimental
Arm Description
Participants receiving IPR + GMI will complete a 30-minute on-line intervention via qualtrics that covers the following topics: (1) Educate youth and caregiver that thoughts and emotions are not fixed but are malleable and subject to change; (2) provide youth and families with a brief intervention that instills hopefulness through an action plan for managing internalizing symptoms; (3) assist with developing system of support to access during times of distress; and (4) educate the caregiver on the importance of these interventions.
Intervention Type
Behavioral
Intervention Name(s)
IPR + GMI
Intervention Description
The IPR + GMI intervention aims to impact reported hopelessness, attitudes to treatment, and view of self as changeable as well as targets treatment attendance and utilization.
Primary Outcome Measure Information:
Title
Change from baseline in child and parental attitudes towards therapy at 4 weeks
Description
Child and parental attitudes towards therapy will be assessed via Attitudes Towards Therapy Scale, as the primary outcome of Bridging the Gap. Scores on this one question assessment range from 0= view of therapy as not at all helpful to 10= view of therapy as very helpful.
Time Frame
Baseline vs. 4 week follow-up
Title
Change from baseline in view of emotions as changeable at 4 weeks
Description
Child and parental views of personality as changeable will be assessed via Implicit Theory of Emotions Scale, as the primary outcome of Bridging the Gap. The Implicit Theory of Emotion contains 4 questions, with two incremental items and two entity items. Each item is rated using a 7-point Likert scale with 1= strongly disagree and 7= strongly agree. The two entity items are reverse-scored. Scores range from 4-28 and higher scores indicate a view of emotions as changeable.
Time Frame
Baseline vs. 4 week follow-up
Title
Change from baseline in view of personality as changeable at 4 weeks
Description
Child and parental views of personality as changeable will be assessed via Implicit Theory of Personality Questionnaire, as the primary outcome of Bridging the Gap. The Implicit Theory of Personality Questionnaire contains 3 questions with a range of scores from 3 to 18, with lower scores indicating a view of personality as changeable.
Time Frame
Baseline vs. 4 week follow-up
Title
Hopelessness
Description
Child and parent hopelessness will be assessed via Beck Hopelessness Short Scale, as the primary outcome of Bridging the Gap. This 4-item scale is totaled using the sum of item scores. Scores range from 0-12, with higher scores indicating more hopelessness.
Time Frame
Up to 4 weeks after baseline
Secondary Outcome Measure Information:
Title
Anxiety Severity
Description
Child anxiety severity will be assessed via SCARED 5-item, as a secondary outcome of Bridging the Gap. This 5-item assessment has scores ranging from 0-10, with higher scores indicating more self-reported anxiety.
Time Frame
Up to 4 weeks after baseline
Title
Depression Severity
Description
Child and parent depression severity will be assessed via MFQ questionnaire, as a secondary outcome of Bridging the Gap. The MFQ Child version has scores ranging from 0-66, with a higher score indicating more severe depression. The MFQ Parent version has scores ranging from 0-69, with higher score indicating more severe depression.
Time Frame
Up to 4 weeks after baseline
Title
Psychological distress
Description
Child and parent psychological distress will be assessed via PHQ4 questionnaire, as a secondary outcome of Bridging the Gap. The PHQ4 contains 4 questions, 2 questions relating to depression and 2 questions relating to anxiety, with scores ranging from 0-12. Higher scores on the PHQ4 indicate more severe psychological distress.
Time Frame
Up to 4 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Goldstein, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Brent, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
Children's Community Pediatrics (CCP- Armstrong Kittanning) of Children's Hospital of Pittsburgh of UPMC
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
IPD Sharing Time Frame
These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
IPD Sharing Access Criteria
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.

Learn more about this trial

Bridging the Gap to Improve Mental Health Treatment Utilization

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