Bridging the Gap to Improve Mental Health Treatment Utilization

NCT04558489 | Withdrawn DMC

• 2 other identifiers: STUDY19110071P50MH115838-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Adolescent Behavior; Suicidal Ideation

Keywords

depression; pediatric primary care; adolescent behavior; mood disorder; technology; provider; intervention

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Anxiety Severity

  Up to 4 weeks after baseline

• Depression Severity

  Up to 4 weeks after baseline

• Psychological distress

  Up to 4 weeks after baseline

Study Arms (1)

IPR + GMI

EXPERIMENTAL

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

Interventions

IPR + GMI BEHAVIORAL

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.

IPR + GMI

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients presenting with depression and/or anxiety, as identified by the patient, parent, or provider
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Kaiser Foundation Research Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

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

Kittanning, Pennsylvania, 16201, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Adolescent Behavior; Suicidal Ideation; Mood Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Suicide; Self-Injurious Behavior

Study Officials

• Tina Goldstein, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• David Brent, MD

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study will use an open trial design, where all participants will receive the Growth Mindset Intervention.

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 22, 2020
• Study Start: December 30, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
• Access Criteria: In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.

Locations

US (1)