An interventional study of IPR + GMI in Depression, Anxiety and Adolescent Behavior, sponsored by University of Pittsburgh. Withdrawn at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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.
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:
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Exclusion Criteria:
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.
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.
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.
Time frame: Baseline vs. 4 week follow-up
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.
Time frame: Baseline vs. 4 week follow-up
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.
Time frame: Baseline vs. 4 week follow-up
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.
Time frame: Up to 4 weeks after baseline
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.
Time frame: Up to 4 weeks after baseline
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.
Time frame: Up to 4 weeks after baseline
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.
Time frame: Up to 4 weeks after baseline
Plan to share: Yes — 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.
No publications or documents are linked to this record.
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