MedDataX Logo

Trial Outcomes & Findings for What Treatment Works for Children With Selective Mutism? (NCT NCT00554749)

NCT ID: NCT00554749

Last Updated: 2010-11-25

Results Overview

SSQ is a teacher-report measure assessing the frequency of the child's speaking behaviour at school. It is a 9-item questionnaire. Each item has four possible responses, ranging 0 (never), 1 (seldom), 2 (often) and 3 (always). The standard sum score is added up from the six questions (as defined by its author Lindsey Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3.(worst value=0 and best value=3)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

6 months

Results posted on

2010-11-25

Participant Flow

November, 2007 to July, 2008.Location: medical clinic

Participant milestones

Participant milestones
Measure
Behavioral
All participants received identical behavioral treatment with no control group.
Overall Study
STARTED
7
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

What Treatment Works for Children With Selective Mutism?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Behavioral
n=7 Participants
All participants received identical behavioral treatment with no control group.
Age, Categorical
<=18 years
7 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age Continuous
4.30 years
STANDARD_DEVIATION 0.75 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Region of Enrollment
Norway
7 participants
n=5 Participants
School speech questionnaire (SSQ)
0.59 units on a scale
STANDARD_DEVIATION 0.51 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

SSQ is a teacher-report measure assessing the frequency of the child's speaking behaviour at school. It is a 9-item questionnaire. Each item has four possible responses, ranging 0 (never), 1 (seldom), 2 (often) and 3 (always). The standard sum score is added up from the six questions (as defined by its author Lindsey Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3.(worst value=0 and best value=3)

Outcome measures

Outcome measures
Measure
Behavioral
n=7 Participants
All participants received identical behavioral treatment with no control group.
School Speech Questionnaire (SSQ)
2.68 Units on a scale
Standard Deviation 0.35

SECONDARY outcome

Timeframe: 6 months

Population: All participants analyzed

6 Predefined treatment goals reflecting speaking levels from 1 through to 6. 1: Speaks to the therapist(T) in a separate room in the kindergarten with parent (P) present. 2: Speaks to T in a separate room without P. 3: Speaks to a teacher in a separate room with T present. 4: Speaks to other teachers in a separate room with T present. 5: Speaks to teachers in some kindergarten settings without T present. 6: Speaks to teachers in all settings in kindergarten without T present. Each child receives one score at end of treatment according to their acquired level (worst value=1, best value =6)

Outcome measures

Outcome measures
Measure
Behavioral
n=7 Participants
All participants received identical behavioral treatment with no control group.
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
Level 6
6 participants
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
Level 5
1 participants
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
Level 4
0 participants
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
Level 3
0 participants
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
Level 2
0 participants
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
Level 1
0 participants

Adverse Events

Behavioral

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hanne Kristensen

Centre for Child and Adolescent Mental Health, Eastern and Southern Norway

Phone: +4722586000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place