Integrated Behavioral Therapy for Treating Children With Selective Mutism (NCT00458198) | Clinical Trial Compass
CompletedNot Applicable
Integrated Behavioral Therapy for Treating Children With Selective Mutism
United States21 participantsStarted 2006-01
Plain-language summary
This study will determine the effectiveness of integrated behavior therapy in treating children with selective mutism.
Who can participate
Age range
4 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of selective mutism
* Score of less than 60 on the Childrens Global Assessment Scale (CGAS)
* Has lived continuously with a primary caretaker who has known the child well for at least 6 months prior to study entry and is legally able to sign the consent form
Exclusion Criteria:
* Diagnosis of any of the following psychiatric disorders: bipolar disorder, pervasive developmental disorder (e.g., Asperger's, autism), mental retardation, or psychotic disorder
* Possibility that a communication disorder may account for the selective mutism
* Current use of or a clinical indication for use of psychotropic medication (youth entering study on a stable psychostimulant regimen for ADHD will not be excluded)
* History of unsuccessful treatment with cognitive behavioral therapy for anxiety that occurred within 2 years prior to study entry
* Any major neurological disorder or major medical illness that may prevent study participation
* Child and/or parent is not English-speaking and is unable to complete measures or treatment without the assistance of a dedicated translator
* Child is not currently attending school (including pre-school), day camp, or other structured daily activity, or has missed more than 50% of school days in the 2 months prior to study entry
* Child's primary teacher is unwilling or unable to participate in the treatment plan
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.