Treatment for Youth (Ages 8 to 16 Years Old) With Misophonia (U-HEAR)
U-HEAR
Unified Protocol to Help Emotions and Promote Auditory Relief (U-HEAR).
1 other identifier
interventional
124
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2020
CompletedFirst Submitted
Initial submission to the registry
April 22, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 28, 2020
April 1, 2020
1.9 years
April 22, 2020
April 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Improvement in symptoms measured by Clinical Global Impression - Improvement (5 weeks)
Clinical Global Impression-Improvement (CGI-I) is a 7-point clinician rated scale of treatment response anchored by 1 (very much improved) and 7 (very much worse). For categorical secondary outcomes, response is defined as a CGI-I rating of 1 or 2 (much improved/very much improved), and remission as CGI-S of 1 to 2. CGI-I will be used to measure symptom improvement after 5 weeks of treatment.
5 weeks
Improvement in symptoms measured by Clinical Global Impression - Improvement (10 weeks)
Clinical Global Impression-Improvement (CGI-I) is a 7-point clinician rated scale of treatment response anchored by 1 (very much improved) and 7 (very much worse). For categorical secondary outcomes, response is defined as a CGI-I rating of 1 or 2 (much improved/very much improved), and remission as CGI-S of 1 to 2. CGI-I will be used to measure symptom improvement after 10 weeks of treatment.
10 weeks
Severity of symptoms measured by Clinical Global Impression - Severity (Baseline)
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). Severity will be measured before treatment begins to create a baseline for each participant.
Baseline
Severity of symptoms measured by Clinical Global Impression - Severity (5 weeks)
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). CGI-S will be used to measure severity after 5 weeks of treatment.
5 weeks
Severity of symptoms measured by Clinical Global Impression - Severity (10 weeks)
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). CGI-S will be used to measure severity after 10 weeks of treatment.
5 weeks
Overall impairment measured by Child's Global Assessment Scale (Baseline)
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100. General functioning of the participant will be measured before treatment begins to create a baseline for each subject.
Baseline
Overall impairment measured by Child's Global Assessment Scale (5 weeks)
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100). CGAS will be used to measure general functioning after 5 weeks of treatment.
5 weeks
Overall impairment measured by Child's Global Assessment Scale (10 weeks)
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100). CGAS will be used to measure general functioning after 10 weeks of treatment.
10 weeks
Secondary Outcomes (6)
Misophonia symptoms as measured by Misophonia Assessment Questionnaire
Baseline
Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire
5 weeks
Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire
10 weeks
Misophonia symptoms as measured by Misophonia Questionnaire
Baseline
Change in misophonia symptoms as measured by Misophonia Questionnaire
5 weeks
- +1 more secondary outcomes
Study Arms (2)
UP-C/A for Misophonia
EXPERIMENTALThe 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.
Psychoeducation and Relaxation Therapy
EXPERIMENTALPsychoeducation 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
Please see arm/group descriptions
Please see arm/group descriptions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- University of Miamicollaborator
Study Sites (2)
Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program at the University of Miami
Coral Gables, Florida, 33124, United States
University of Florida Rothman Center
St. Petersburg, Florida, 33701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Lewin, PhD
University of South Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor and Interim Division Chief
Study Record Dates
First Submitted
April 22, 2020
First Posted
April 28, 2020
Study Start
April 8, 2020
Primary Completion
March 1, 2022
Study Completion
December 1, 2022
Last Updated
April 28, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Approximately 2 years following the completion of the analyses. Duration of the availability is at Sponsor's discretion.
- Access Criteria
- Access is at Sponsor's discretion.
The sponsor requests de-identified data as a grant requirement in order to better the understand of misophonia. At the conclusion of the study, we will provide the de-identified data.