Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

NCT ID: NCT03612102

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-11

Study Completion Date

2017-12-14

Brief Summary

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This goal of this study is to evaluate an intensive group behavioral treatment (IGBT) program for children with selective mutism, a low base-rate childhood anxiety disorder. 29 children between the ages of 5 and 9 will be randomly assigned to participate in a 5-day IGBT over the summer or to a waitlist control condition, with the opportunity to participate in IGBT 4 weeks later. All children that participate in treatment will be followed up 8 weeks into the following school year.

Detailed Description

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Conditions

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Selective Mutism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Families of children with selective mutism will be randomly assigned to receive either immediate intensive group behavioral treatment (IGBT) or to a waitlist with psychoeducational materials, and then IGBT.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
"Independent evaluators" assigned to assess outcomes will be masked to whether or not families participated in IGBT or were at the end of their waitlist period.

Study Groups

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Treatment

The treatment consists of a 5-day intensive group behavioral treatment program (IGBT)

Group Type ACTIVE_COMPARATOR

Intensive Group Behavioral Treatment (IGBT)

Intervention Type BEHAVIORAL

IGBT is a 5-day intensive treatment program, where cognitive behavioral therapy is provided to children and their parents delivered over 6-8 hours per day over the course of 5 days.

Waitlist

The waitlist consists of a 4-week waitlist period where parents will be provided with psychoeducational materials about their child's condition (i.e., selective mutism). After the 4-week waitlist period, families will be provided with the opportunity to participate in IGBT.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive Group Behavioral Treatment (IGBT)

IGBT is a 5-day intensive treatment program, where cognitive behavioral therapy is provided to children and their parents delivered over 6-8 hours per day over the course of 5 days.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meets diagnostic criteria for selective mutism
* Verbal with at least 1 parent or caregiver
* Child fluent in English

Exclusion Criteria

* Any mental health difficulty significantly more impairing than selective mutism
Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

American Psychological Association (APA)

OTHER

Sponsor Role collaborator

Florida International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Florida International University

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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800008139

Identifier Type: -

Identifier Source: org_study_id

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