Silva et al., 2007

Study DescriptionInterventionInclusion/Exclusion
Criteria/Population
Baseline MeasuresOutcomes
Author:
Silva et al., 2007
Country:
US
Practice setting:
Academic
Intervention setting:
Clinic and home
Enrollment period:
August 2005
Funding:
Spirit Mountain community fund & Brigid Kildare
Author industry relationship disclosures:
NR
Design:
RCT with continuation
Note:
See related papers Silva et al., 2008, 2009 {#58:#5051}
Intervention:
Qigong Massage movements (Cignolini methodology)
Treatment given twice weekly for two 5 week periods with 5 weeks in-between by trained practitioner; parent administers the same treatment at least once daily for 5 months Children stratified into 3 groups according to Battele Developmental Inventory cognitive scores then randomly assigned to treatment and control within each cognitive group
All children attended pre- school classrooms 2–4 times/week for 2 hours at the Willamette Education Service District
Assessments:
Principal author provided initial evaluation of child, including administering Batelle Developmental Inventory Blinded examiners administered VABS and ABC tests and parents completed a sensory profile questionnaire pre- and post-treatment; exit interview with parents administered post- treatment. Several treatment visits and the exit interview were videotaped.
Groups:
G1: Cignolini method
G2: controls
Provider:
Parent and trained practitioner
Measure of treatment fidelity reported:
NR
Inclusion criteria:
  • Formal diagnosis of uncomplicated autism according to DSM-IV
  • Age up to 6 years
  • Parental commitment to give massage every day for 5 months and get the child to the clinic to get prescription from the doctor 20 times
  • Willingness of the parent not to try any new treatments while in this study
Exclusion criteria:
  • Children with other neurological conditions such as seizures
  • Chronic medication
Age, years (range):
4.83 (3–6)
Mental age:
NR
Gender, n (%):
Male: 13 (86.7)
Female: 2 (13.3)
Race/ethnicity:
NR
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
In study
Diagnostic tool/method:
DSM-IV by medical specialists
Diagnostic category, n (%):
Autism: 15 (100)
Other characteristics:
NR
Social skills:
VABS socialization, score, mean:
G1: 29.8
G2: 24.7
Communication/language:
VABS receptive language score, mean:
G1: 33.8
G2: 23.6
VABS expressive language score, mean:
G1: 31.5
G2: 24.4
Adaptive behavior:
ABC score, mean:
G1: 71.3
G2: 87.7
VABS daily living skills, mean:
G1: 28.8
G2: 24.1
Motor skills:
VABS gross motor skills score, mean:
G1: 37.5
G2: 33.4
VABS fine motor skills, mean:
G1: 36
G2: 29
Sensory:
Sensory profile score, mean:
Total (items A-N):
G1: 16.2
G2: 15.7
Processing (items A-F):
G1: 7.2
G2: 7.1
Modulation (items G-K):
G1: 5.3
G2: 5
Social skills:
VABS socialization, score, mean change:
G1: 10
G2: 4.7
G1/G2: P = 0.04
Communication/language:
VABS receptive language score, mean change:
G1: 8.3
G2: 10.6
G1/G2: P = NS
VABS expressive language score, mean change:
G1: 8.9
G2: 6.7
G1/G2: P = NS
Adaptive behavior:
ABC score, mean change:
G1: −13.3
G2: −24.3
G1/G2: P = NS
VABS daily living skills, mean change:
G1: 9.8
G2: 0.9
G1/G2: P = 0.02
Motor skills:
VABS gross motor skills score, mean change:
G1: 6.5
G2: 0.9
G1/G2: P = NS
VABS fine motor skills, mean change:
G1: 8.8
G2: 7.6
G1/G2: P = NS
Co-interventions held stable during treatment:
See inclusion criteria
Concomitant therapies, n (%):
Speech therapy: 4/15 (26)
N at enrollment:
G1: 8
G2: 7
N at follow-up:
G1: 13*
G2: 7
Behavioral/emotional abnormality (items L-N):
G1: 3.6
G2: 3.6
Factor scale (factors 1–8):
G1: 8.5
G2: 8.7
Sensory:
Sensory profile score, mean change:
Total (items A-N):
G1: −5.4
G2: 2.7
G1/G2: P = 0.01
Processing (items A-F):
G1: −2.4
G2: 1
G1/G2: P = 0.01
Modulation (items G-K):
G1: −1.9
G2: 1
G1/G2: P = 0.02
Behavioral/emotional abnormality (items L-N):
G1: −1.1
G2: 0.7
G1/G2: P = 0.02
Factor scale (factors 1–8):
G1: −3.1
G2: 1.4
G1/G2: P = 0.02

Medical:
Improvement in bowel and sleep abnormalities, n:
G1: 8/8
G2: 0
Harms:
NR
Modifiers:
NR

Comments:

*

The authors state that because the treatment was beneficial, after the RCT phase the 7 controls were offered the treatment. One child could not participate because of his mother’s severe health problems, and one child began treatment but moved from the area after completing only 9 weeks. The pre- and post-treatment measures of 5 controls in the continuation phase are included in the baseline and outcome measures reported (the authors do not report the measures separately for the original treatment group and continuation group).

**

The authors do not report standard deviations or standard errors, but do report the Kruskal Wallace H statistic.

The authors state that because the treatment was beneficial, after the RCT phase the 7 controls were offered the treatment. One child could not participate because of his mother’s severe health problems, and one child began treatment but moved from the area after completing only 9 weeks. The pre- and post-treatment measures of 5 controls in the continuation phase are included in the baseline and outcome measures reported (the authors do not report the measures separately for the original treatment group and continuation group).

From: Appendix C, Evidence Tables

Cover of Therapies for Children With Autism Spectrum Disorders
Therapies for Children With Autism Spectrum Disorders.
Comparative Effectiveness Reviews, No. 26.
Warren Z, Veenstra-VanderWeele J, Stone W, et al.

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