Recruiting

U-HEAR

Sponsor:

University of South Florida

Code:

NCT04365543

Conditions

Misophonia

Eligibility Criteria

Sex: All

Age: 8 - 16

Healthy Volunteers: Not accepted

Interventions

Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia

Psychoeducation and Relaxation Therapy (PRT)

Study Details

Brief summary:

If someone is really sensitive to certain noises and sounds, they might have misophonia. U-HEAR is a study created to find out what helps kids and teens with misophonia. There are two treatments being tested in this study. The treatment your child receives will be determined at random. There will be a Two-Thirds (2/3rds or 66%) chance your child will receive a treatment called the Unified Protocol for Children and Adolescents (UP-C/A) that has been modified to meet the needs for youth with misophonia. There is a One-Third (1/3rd or 33%) chance your child will receive a treatment called Psychoeducation and Relaxation. All participants will get ten free treatment sessions. Each session will last one hour and happen once a week. The aim of the study is to evaluate the feasibility and preliminary efficacy of the UP-C/A for youth with misophonia.

Conditions

Misophonia

Study ID

NCT04365543

Start date

Apr 8, 2020

Status verified date

Apr, 2020

Completion date

Dec, 2022

Anticipated

Primary completion date

Mar, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The child meets criteria for misophonia
  • The child is currently living with their family/guardian(s)
  • The child is between 8 and 16 years old
  • Parent/legal guardian and child are able to read and speak English without a translator
  • Parent/legal guardian is able to attend weekly sessions and all assessments
  • If the child is on a psychotropic medication, they will need to be on a stable dose for 4 weeks prior to assessment (2 weeks for stimulant medication)

Exclusion Criteria:

  • The child has received prior UP-C/A treatment
  • The child is acutely suicidal
  • The child has a current diagnosis of psychosis, bipolar disorder, intellectual disability, alcohol/substance dependence, or eating disorder

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UP-C/A for Misophonia

The Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) are manualized treatments for treating emotional disorders in youth. We have modified the UP-C/A to meet the needs for youth with misophonia.

experimental: Psychoeducation and Relaxation Therapy

Psychoeducation and Relaxation Therapy (PRT) is a treatment that educates the child on misophonia and provides training in relaxation skills and tools for calming panic, anxiety and anger feelings.

Interventions

Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia

Please see arm/group descriptions

Psychoeducation and Relaxation Therapy (PRT)

Please see arm/group descriptions

Primary outcome measure

  • Improvement in symptoms measured by Clinical Global Impression - Improvement (5 weeks) [ Time Frame: 5 weeks ]
  • Improvement in symptoms measured by Clinical Global Impression - Improvement (10 weeks) [ Time Frame: 10 weeks ]
  • Severity of symptoms measured by Clinical Global Impression - Severity (Baseline) [ Time Frame: Baseline ]
  • Severity of symptoms measured by Clinical Global Impression - Severity (5 weeks) [ Time Frame: 5 weeks ]
  • Severity of symptoms measured by Clinical Global Impression - Severity (10 weeks) [ Time Frame: 5 weeks ]
  • Overall impairment measured by Child's Global Assessment Scale (Baseline) [ Time Frame: Baseline ]
  • Overall impairment measured by Child's Global Assessment Scale (5 weeks) [ Time Frame: 5 weeks ]
  • Overall impairment measured by Child's Global Assessment Scale (10 weeks) [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Kelly Kudryk, BA

813-586-1630kellykudryk@miami.edu

Jane Mutch, PhD

727-767-8230rothmanctr@usf.edu

Locations

Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program at the University of Miami

Recruiting

Coral Gables, Florida, United States, 33124

Contacts

Ashley Karlovich, BA

305-284-9852anxietylab@psy.miami.edu

University of Florida Rothman Center

Recruiting

Saint Petersburg, Florida, United States, 33701

Contacts

Kelly Kudryk, BA

813-586-1630kellykudryk@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Apr 28, 2020

Last verified

Apr, 2020

Keywords

  • misophonia
  • sensory sensitivity
  • anxiety
  • sound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of South Florida on 2020-04-28.