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New treatment option for Prader-Willi Syndrome
Official title Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation
ClinicalTrials.gov ID: NCT07607730
What this study is testing
- What it's testing
- The goal of this study is to help teens with Prader-Willi Syndrome (PWS) and their families learn practical strategies for managing issues like irritability, meltdowns, and anxiety. The main objective of the study is: To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in Prader-Willi Syndrome (PWS) that will improve psychosocial outcomes for youth with PWS.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 17
You may be able to join if
- Child Participant
- Ages 13-17.5 years
- Confirmed genetic diagnosis of Prader-Willi Syndrome
- Fluent in spoken English
- Adolescent's use of flexible phrase speech or greater
You likely can't join if
- Initiation of new psychosocial intervention within 30 days prior to first day of treatment
- Presence of physical aggression in the adolescent directed towards a peer outside the home that resulted in injury within 30 days prior to screening
- Presence of comorbid major neuropsychiatric illness warranting other treatment approaches
- Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss Caregiver...
- Age ≥ 18 years
- Lives and cares for their child with PWS for \> 50% of the year
See the full eligibility criteria
- Child Participant
- Ages 13-17.5 years
- Confirmed genetic diagnosis of Prader-Willi Syndrome
- Fluent in spoken English
- Adolescent's use of flexible phrase speech or greater
- Meeting clinically significant emotional dysregulation criteria
- Willing to participate in weekly 90-minute group sessions
- Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable
- Parent, guardian, or legally authorized representative must provide written permission on behalf of the participant Child Participant
- Initiation of new psychosocial intervention within 30 days prior to first day of treatment
- Presence of physical aggression in the adolescent directed towards a peer outside the home that resulted in injury within 30 days prior to screening
- Presence of comorbid major neuropsychiatric illness warranting other treatment approaches
- Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss Caregiver Inclusion Criteria:
- Age ≥ 18 years
- Lives and cares for their child with PWS for \> 50% of the year
- Fluent in spoken English
- Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly Caregiver Exclusion Criteria: -Presence of any major sensory impairment that would limit participating in the material...
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.