A Phase 1/2 interventional study of Parent-Led Exposure Therapy and Treatment As Usual in Obsessive-compulsive Disorder, Social Phobia and Generalized Anxiety Disorder, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2016-10-06.
Sponsored by University of South Florida · Phase 1/2, Interventional, and Treatment
Behaviorally and cognitive-behaviorally based therapeutic techniques (BT; CBT) that incorporate exposure therapy useful for treatment of anxiety disorders among typically developing children. Although a large amount of data demonstrate the effectiveness of of BT and CBT approaches for treating anxious youth, there is a gap in the literature for the effectiveness of these approaches for children under the age of seven. Evidence increasingly suggests that family factors such as accommodation and parenting style contribute significantly to the presence of anxiety symptoms as well as treatment outcomes, particularly in young children. These findings stress the importance of using a treatment approach in which parents are directly involved in education, parent training, and generalization of treatment effects. Therefore, this study aims to evaluate a new treatment program, parent-led behavioral treatment, for children ages 3 to 7 years of age who have a principal anxiety disorder diagnosis.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's enrollment of 58 is above the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(a) Current suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Therapists will work with families for 10 sessions, twice weekly. The first treatment session will be a 90 minute parent only psychoeducation and treatment preparation session. Each subsequent session will last up to 60 minutes and will consist of exposure therapy using developmentally appropriate modulated behavioral approaches such as Participant modeling (PM) and Reinforced practice (RP).
Behavioral: Parent-Led Exposure Therapy
Patients randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice.
Other: Treatment As Usual
Therapists will work with families for 10 sessions, twice weekly. The first treatment session will be a 90 minute parent only psychoeducation and treatment preparation session. Each subsequent session will last up to 60 minutes and will consist of exposure therapy using developmentally appropriate modulated behavioral approaches such as Participant modeling (PM) and Reinforced practice (RP).
Also known as: Brief Behavioral Treatment for Anxiety in Young Children
Patients randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice. These participants may also elect to receive no treatment at all during the TAU period.
Pediatric Anxiety Rating Scale
The PARS is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week.
Time frame: after 5 weeks of treatment
Clinical Global Impression - Severity
The CGI-S is a 7-point clinician rating of severity of psychopathology anchored by 1 ("no illness") and 7 ("very severe").
Time frame: After 5 weeks of treatment
Clinical Global Improvement
The CGI is a 7-point rating of treatment response anchored by 1 ("very much improved) and 7 ("very much worse"). Youth being rated by the IE as 1 ("very much improved") and 2 ("much improved") will be considered treatment responders.
Time frame: After 5 weeks of treatment
The record gives a start of Jan 2014, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Obsessive-Compulsive Disorder →