Randomised Controlled Treatment Study of Selective Mutism

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk. SM may cause great suffering and create problems, both socially and related to learning. SM is associated with social anxiety, neurodevelopmental delay and bilingualism. The prevalence is about .7-8 ‰. Adequate assessment and treatment of SM is seldom provided in the mental health services. SM is considered hard to treat, and randomised treatment studies are lacking. This study will examine the effect of a manual based treatment for SM. The treatment consists of home- and kindergarten /school based interventions including behaviour techniques and psychoeducation. Defocused communication is a general treatment principle. Comorbidity, including neurodevelopmental delay /disorder, and predictors of outcome, will be examined. A pilot study was conducted to ensure the feasibility of the planned effectiveness study. Seven children, aged 3-5 years were included. Six has started treatment, and all talked in the kinder garden within the first 3 months. The present study will have a randomised controlled design with 1. Manual based intervention for 6 months compared to 2. Waiting list controls (3 months), and then manual based intervention. The sample: Children aged 3-9 years consecutively referred to the school psychology- or the mental health services in Oslo and Eastern Norway. Expected N = 24 based on the pilot study, is a sufficient sample size to answer our primary research question. The treatment will be given by a therapist from the research group or by a local clinician under supervision. The study can add essential knowledge on treatment of SM and make effective treatment available to clinicians in the community.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Factors Influencing Selective Mutism

NCT04233905

Selective Mutism

COMPLETED

Auditory Prediction and Error Evaluation in the Speech of Individuals Who Stutter

NCT06181149

Healthy Subjects Stuttering, Developmental

RECRUITING NA

Stimulation of the Thalamus to Ameliorate Persistent Disfluency

NCT05641701

Persistent Developmental Stutter Childhood-Onset Fluency Disorder (Stuttering)

UNKNOWN NA

Speech Signals in Stuttering

NCT05668923

Stuttering, Childhood

RECRUITING NA

VR Homework Exercises for Selective Mutism Treatment

NCT06882629

Selective Mutism Anxiety Disorder of Childhood

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Selective Mutism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

stimulus fading procedures

Group Type EXPERIMENTAL

Stimulus fading procedures

Intervention Type BEHAVIORAL

Core elements : 1.Behavior techniques (BT's) are used to gradually master the anxiety ("stimulus fading" and reward).

2\. Children are first met at home where they feel most safe, and the BT's are first conducted at home in cooperation with the parents.

3.The same interventions are then continued in the environment where the problem primarily exist (kindergarten / school) not at the clinic.

4.Defocused communication- and interaction is a general treatment principle (e.g. avoid looking directly at the child, sit beside not opposite to the child, no direct questioning, and communication is based upon a motivating activity, not about the child).

5.Frequent and short interventions. 6.Information to parents and teachers on how to communicate with children with SM

Guidance on defocused communication

Intervention Type BEHAVIORAL

Guidance and supervision to teachers working with the children with SM. Frequency: Twice during three months

guidance of defocused communication

Group Type ACTIVE_COMPARATOR

Guidance on defocused communication

Intervention Type BEHAVIORAL

Guidance and supervision to teachers working with the children with SM. Frequency: Twice during three months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stimulus fading procedures

Core elements : 1.Behavior techniques (BT's) are used to gradually master the anxiety ("stimulus fading" and reward).

2\. Children are first met at home where they feel most safe, and the BT's are first conducted at home in cooperation with the parents.

3.The same interventions are then continued in the environment where the problem primarily exist (kindergarten / school) not at the clinic.

4.Defocused communication- and interaction is a general treatment principle (e.g. avoid looking directly at the child, sit beside not opposite to the child, no direct questioning, and communication is based upon a motivating activity, not about the child).

5.Frequent and short interventions. 6.Information to parents and teachers on how to communicate with children with SM

Intervention Type BEHAVIORAL

Guidance on defocused communication

Guidance and supervision to teachers working with the children with SM. Frequency: Twice during three months

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

stimulus fading technique defocused communication

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children from Eastern \& Southern Norway will be included if they fulfill the diagnostic criteria for SM

Exclusion Criteria

* Children with SM and mental retardation with IQ below 50.
* Children with SM and psychosis or pervasive developmental disorders with the exception of Asperger syndrome and PDD Nos (DSM-IV)
* Children with SM who receive an active treatment for SM in the CAMHS
* Children with SM who are medicated for social anxiety.
* Children with SM where the parents do not understand Norwegian.

Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes