Bridging the Gap to Improve Mental Health Treatment Utilization

Depression Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04558489
• Other study ID #: STUDY19110071
• Secondary ID: P50MH115838-02
• Status: Withdrawn
• Phase: N/A
• Start date: December 30, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Anxiety
• Depression
• Suicidal Ideation

Intervention

Behavioral:
• IPR + GMI
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.

Locations

Country	Name	City	State
United States	Children's Community Pediatrics (CCP- Armstrong Kittanning) of Children's Hospital of Pittsburgh of UPMC	Kittanning	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline vs. 4 week follow-up
Primary	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.	Baseline vs. 4 week follow-up
Primary	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.	Baseline vs. 4 week follow-up
Primary	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.	Up to 4 weeks after baseline
Secondary	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.	Up to 4 weeks after baseline
Secondary	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.	Up to 4 weeks after baseline
Secondary	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.	Up to 4 weeks after baseline