Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adolescent Behavior
  • Anxiety
  • Depression
  • Suicidal Ideation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study will use a parallel study design, where participants are randomized into two intervention groups (IPR+GMI and IPR alone) and will receive interventions in parallel.Masking: Single (Outcomes Assessor)Masking Description: Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.Primary Purpose: Health Services Research

Participation Requirements

Age
Between 10 years and 18 years
Gender
Both males and females

Description

Bridging the Gap purposes to evaluate whether these interventions, designed to instill beliefs that personal traits (including mental health problems) are malleable, can improve parent and child attitudes toward therapy, view of personality as changeable, and hopelessness among children identified a...

Bridging the Gap purposes to evaluate whether these interventions, designed to instill beliefs that personal traits (including mental health problems) are malleable, can improve parent and child attitudes toward therapy, view of personality as changeable, and hopelessness among children identified as experiencing internalizing problems. Patients presenting with depression and/or anxiety will be randomized in a 1:1 allocation ratio with their caregiver into one of two experimental conditions: (1 information, psychoeducation and referral (IPR); or (2) IPR plus a single session on-line intervention for parents and patients oriented to a growth mindset intervention (GMI). Assignment of Interventions: This study will randomize participants via online survey to IPR+GMI or IPR alone 1:1 using Efron's modification of a biased coin-toss, balancing on sex, age (10-14 vs. 15-18), and presence of depression. This study will pilot Bridging the Gap in a community pediatric practice using a biased coin-toss design (n= 100 youth/caretaker dyads). Hypothesis: H1: Impact of GMI on hopelessness, attitudes to treatment, view of self as changeable, anxiety and depression. Multivariate mixed effects regression, testing for treatment by time interactions, with follow-up post-hoc testing of individual measures. H2: Impact of GMI on service use: to test attendance at least one recommended session, will used mixed effects logistic regression; to test for the number of attended sessions, will use mixed effect linear regression. H3: Mediation of impact of GMI on service use Structural equation modelling will be used to test the significance of paths from GMI to hopelessness, attitudes to therapy, belief that self can change, and from these intermediate variable to the outcome of service use.

Tracking Information

NCT #
NCT04558489
Collaborators
  • Kaiser Foundation Research Institute
  • National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Tina Goldstein, PhD University of Pittsburgh Study Director: David Brent, MD University of Pittsburgh