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NCT04291638
Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism
NA trial testing Remote Caregiver Training in Selective Mutism in 11 participants. Completed in 7 December 2020.
7 December 2020
Quick facts
| Lead sponsor | Florida International University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 6 March 2020 |
| Primary completion | 7 December 2020 |
| Estimated completion | 7 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Remote Caregiver Training
- Remote Intensive Group Behavioral Treatment (IGBT)
Conditions studied
- Selective Mutism — all drugs for Selective Mutism →
Sponsor
Florida International University
Who can join
Adults 4 to 10, any sex, with Selective Mutism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study sought to evaluate an innovative post-acute continuation/transition planning treatment strategy that leveraged an in-person intensive treatment followed by online, videoconferencing-based "booster" sessions for youth with selective mutism (SM). Twenty children between the ages of 4 and 10 and their caregivers were scheduled to participate in an in-person intensive group behavioral treatment (IGBT) for SM and subsequently randomized to receive either (a) six, biweekly, hour-long, videoconferencing-delivered booster sessions or (b) no additional treatment for 12 weeks. Due to COVID-19-related physical distancing restrictions, the study team was unable to provide in-person services. Thus, the clinical trial was converted to an open-trial design focused on evaluating remote treatment options (i.e., remotely delivered caregiver training sessions and/or a remotely delivered IGBT) for these families. All families retained in the study have or will participate(d) in assessments at the following time points: Intake (i.e., 4-5 months prior to the remote IGBT); Baseline (i.e., 1 month prior to the IGBT), Post-IGBT (i.e., 2 weeks following the IGBT), and School Year Follow Up (i.e., 16 weeks following the IGBT).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04291638
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Selective Mutism
Currently open trials in the same condition.
- NCT06934525 — Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings · NA · recruiting
Other Florida International University trials
Trials by the same sponsor.
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- NCT06489314 — Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya · NA · enrolling by invitation
- NCT07199361 — Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation · NA · recruiting
- NCT04571502 — Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care · NA · enrolling by invitation
- NCT06637436 — PrEP Readiness Interventions for Sustained Motivation (PRISM) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04291638 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Florida International University
- Last refreshed: 16 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04291638.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing