Intensive Stuttering Group Therapy for School-age Children and the Effect of Emotional Reactivity on Therapy Outcomes

NCT03778632 | Completed

• 1 other identifier: 16/621-15
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objectives of this investigation were two-fold: 1) to investigate whether implementation of individualized desensitization exercises in an intensive stuttering group therapy for school-age children who stutter is superior to the standard application of intensive stuttering group therapy, 2) to examine the relationship between exhibited emotional reactivity (positive and negative affect) and stuttering recovery rates. Secondary objectives included: 1) investigating whether cognitive, affective, linguistic and social scores differ with treatment and, 2) heart rate and skin conductance changes associated with the stuttered utterance during intensive stuttering group therapy activities. Twelve children (8 to 12 years of age, with equal randomization \[1:1\]) randomized to two groups; 1) Study group, individualized desensitization exercises implemented in 2 weeks of intensive stuttering group therapy(n=6), 2) Control group, 2 weeks of standard intensive stuttering group therapy(n=6). Children were blinded to treatment arm. The first part of this study was a superiority trial of individualized desensitization exercises in intensive stuttering group therapy. The second part of the study was conducted with the study group during the daily therapy activities of intensive stuttering group therapy to investigate the emotion's effect on therapy outcomes with behavioral and physiological measures.

Conditions

Stuttering, Childhood; Emotion, Expressed

Keywords

Stuttering; School-age; Emotional reactivity; Wearable technology

Outcome Measures

Primary Outcomes (2)

• The stuttering severity

  Comparison of control group and study group by Turkish version of Stuttering Severity Instrument-4 score change.Stuttering Severity Instrument-4 is an instrument that measures stuttering severity of children in the age range of 6 to16 years. This instrument measures stuttering severity by 3 sub-items; 1)frequency, 2)duration, and 3)physical concominants. evaluates speech naturalness of the children's speech. Lowest available score on this instrument is 6 and is equivalent to very mild stuttering and 36\& higher points are equivalent to very severe stuttering.

  One month before therapy to three months after therapy

• Emotional reactivity (positive and negative affect) effect on therapy outcome

  Obtained by means coding behavioral analysis of positive and negative affect. Emotion facial action coding was used to code positive and negative affects. Positive affect coded when the following action units(AU) appeared; AU 12 (extraction of the lip corner) and AU 6 +12 (cheek up with the extraction of the lip corner). Positive affect may be accompanied by AU1 + 2 (eyebrow elevation), AU25 (mouth opening) or AU 26 (loosening of jaw). If AU12 occurs without AU6, AU12 should occur at least C severity in the intensity classification from 5 to likert type A to E If AU12 is present with AU6, the intensity of AU12 is B. For the acceptance of affect as negative; AU 9 (nose creasing); AU 10 (upper lip elevation); AU 14 (pitting); AU 15 (depression of the lip corner); it is necessary that at least one of the codes AU 20 (lips stretching) and AU 1 + 4 (lifting the eyebrows to the midline and approaching) occur at intensity B.

  Collected during first 3 days of the intensive stuttering group therapy to compare the therapy outcomes

Secondary Outcomes (3)

• Changes in cognitive, affective, linguistic and social scores

  One month before therapy to three months after therapy

• Heart rate changes

  Collected during first 3 days of the intensive stuttering group therapy

• Skin conductance changes

  Collected during first 3 days of the intensive stuttering group therapy

Study Arms (2)

Study Group

EXPERIMENTAL

Intensive stuttering group therapy which was included individualized desensitization exercises was applied with the study group. Family training was applied with the parents a month before the therapy. Ten days (4.5 hours a day, a total of 45 hours therapy) of intensive stuttering group therapy was applied.

Behavioral: individualized desensitization exercises

Control Group

ACTIVE COMPARATOR

Standard intensive stuttering group therapy was applied with the control group. Family training was applied with the parents a month before the therapy. Ten days (4.5 hours a day, a total of 45 hours therapy) of intensive stuttering group therapy was applied.

Behavioral: individualized desensitization exercises

Interventions

individualized desensitization exercises BEHAVIORAL

implementing individualized desensitization exercises in standard application of intensive stuttering group therapy for school-age children who stutter

Control Group; Study Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• very mild to moderate stuttering based on Stuttering Severity Instrument-4-Turkish Version
• no history of intellectual, emotional, academic, hearing, neurological, physiological problems based on parental report
• no history of speech and/or language problems other than stuttering
• not to be received stuttering therapy during the previous six months.

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mavis Emel Kulak Kayikci, Assoc. Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 19, 2018
• Study Start: October 25, 2016
• Primary Completion: May 2, 2018
• Study Completion: June 20, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF