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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04558489
Other study ID # STUDY19110071
Secondary ID P50MH115838-02
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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