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Regulating Together for Autism
N/A
Recruiting
Led By Rebecca Shaffer
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult
Awards & highlights
Study Summary
This trial aims to help young people with autism improve their emotion regulation and overall mental health.
Who is the study for?
This trial is for English-speaking caregivers and their children with autism spectrum disorder (ASD) who are 11-12 years old, have functional verbal communication, an IQ score of 65 or higher, and issues with emotion regulation. Families must commit to twice-weekly sessions and keep current medications stable. Children with major sensory impairments, recent psychosocial interventions, a history of serious aggression, or other major neuropsychiatric illnesses are excluded.Check my eligibility
What is being tested?
The study aims to validate 'Regulating Together' (RT), an intervention designed to help youth with ASD manage their emotions better compared to 'Achieving Independence and Mastery in School' (AIMS). Participants will attend twice-weekly sessions for either RT or AIMS based on random assignment.See study design
What are the potential side effects?
Since the interventions involve behavioral therapy rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or fatigue due to the intensity of the therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Emotion Dysregulation Inventory- Reactivity
Secondary outcome measures
Children's Organizational Skills Scale (COSS)
Daily Phone Diary
Inpatient Hospitalization Rates
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Regulating Together (RT)Experimental Treatment1 Intervention
Participants will receive Regulating Together -the emotion dysregulation intervention
Group II: Achieving Independence and Mastery in School (AIMS)Active Control1 Intervention
Participants will receive AIMS, the academic functioning/organizational skill intervention.
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,447 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,555 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,590 Previous Clinical Trials
2,281,338 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a major mental health condition needing different treatment.My guardian and I (if I'm 11-12 years old) have given written consent to participate.I am willing to attend two 90-minute sessions weekly.I do not have major sensory impairments like blindness or severe hearing loss.I have been diagnosed with autism spectrum disorder.I started a new mental health support program within the last 30 days.My family agrees to not change my medications or seek other treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Achieving Independence and Mastery in School (AIMS)
- Group 2: Regulating Together (RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any individuals being sought for participation in this research endeavor?
"Affirmative. As evidenced on clinicaltrials.gov, this scientific research is still looking for participants and was first posted on August 1st 2022 with the most recent update being March 27th 2023. There are currently 144 positions at a single location open to volunteers."
Answered by AI
Is the age restriction for enrollment in the experiment higher than thirty-five?
"This clinical trial is seeking applicants aged 8 to 12. Of the 294 trials hosted on this platform, 237 are applicable for minors and 57 serve seniors above 65 years old."
Answered by AI
Is this research project open to volunteer participants?
"To meet the requirements for this trial, candidates must have a diagnosis of autism and be between 8-12 years old. A total of 144 patients will eventually participate in this clinical research."
Answered by AI
What is the scale of this clinical investigation?
"Affirmative. According to the statistics on clinicaltrials.gov, this research is still recruiting volunteers with a start date of August 1st 2022 and an update from March 27th 2023. The team requires 144 participants from one medical centre for their investigation."
Answered by AI
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