Trial Outcomes & Findings for Acupressure and Acupuncture as an Intervention With Children With Autism II (NCT NCT00935701)
NCT ID: NCT00935701
Last Updated: 2017-04-18
Results Overview
COMPLETED
NA
10 participants
2 months into Phase 1
2017-04-18
Participant Flow
Ten children with ASD (8 boys and 2 girls between the ages of 3 and 10 years) and their parents took part in a 16-week intervention. Children were recruited through autism networks and Kennedy Krieger Institute. Phase 2 was not conducted due to difficulty recruiting enough participants to successfully complete a randomized controlled trial.
All participants completed 16 treatment sessions and all parents carried out a home component of treatment during this time period.
Participant milestones
| Measure |
Acupuncture and Acupressure
In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
|
|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
Transition Acupressure to Acupuncture
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Acupuncture and Acupressure
In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
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|---|---|
|
Overall Study
Failure to Transition to Acupuncture
|
1
|
Baseline Characteristics
Acupressure and Acupuncture as an Intervention With Children With Autism II
Baseline characteristics by cohort
| Measure |
Acupuncture and Acupressure
n=10 Participants
In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
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|---|---|
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Age, Categorical
<=18 years
|
10 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
|
6.2 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 months into Phase 1Population: Participants who transitioned from acupressure to acupuncture were assessed.
Outcome measures
| Measure |
Primary Group
n=9 Participants
Phase 1
|
|---|---|
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Proportions of Children Completing Acupressure and Acupuncture Treatment.
|
9 participants
|
SECONDARY outcome
Timeframe: Pre intervention (baseline), post intervention (8 weeks)The Conners' Rating Scales Revised (CRS-R) is used to assess attention deficit hyperactivity disorder (ADHD) as well as other related behavioral concerns. The CRS-R is made up of 14 scales. Analysis was done on 6 of these scales: Conners' Global Index Restless-Impulsive, Conners' Global Index Emotional Lability, Conners' Global Index Total, DSM-IV Inattentive, DSM-IV Hyperactive-Impulsive, and DSM-IV Total. Raw scores are converted to T-scores, based on age and gender of the child. A high T-score indicates a greater number and/or frequency of reported concerns. Pre T-scores were subtracted from post T-scores to calculate the change in T-score.
Outcome measures
| Measure |
Primary Group
n=9 Participants
Phase 1
|
|---|---|
|
Change in Conners' Rating Scales
Restless-Impulsive
|
-8.67 t-scores
Standard Deviation 8.2
|
|
Change in Conners' Rating Scales
Emotional Lability
|
-5 t-scores
Standard Deviation 8.4
|
|
Change in Conners' Rating Scales
Global Index Total
|
-8.11 t-scores
Standard Deviation 8.49
|
|
Change in Conners' Rating Scales
DSM-IV Inattentive
|
-11.11 t-scores
Standard Deviation 8.58
|
|
Change in Conners' Rating Scales
DSM-IV Hyperactive-Impulsive
|
-8 t-scores
Standard Deviation 9.71
|
|
Change in Conners' Rating Scales
DSM-IV Total
|
-9.78 t-scores
Standard Deviation 9.56
|
SECONDARY outcome
Timeframe: Pre intervention (baseline), post intervention (8 weeks)The Children's Sleep Habits Questionnaire (CSHQ) assesses sleep problems common in school-age children and is comprised of eight subscales. Each item receives a score from 1 (meaning the problem occurs rarely) to 3 (meaning the problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: Bedtime Resistance: 6 to 18, Sleep Onset Delay: 1 to 3, Sleep Duration: 3 to 9, Sleep Anxiety: 4 to 12, Night Wakings: 3 to 9, Parasomnias: 7 to 21, Disordered Breathing: 3 to 9, Daytime Sleepiness: 8 to 24, and Total Disturbance (items from all scales): 33 to 99. Subscale scores from pre intervention were subtracted from post subscale scores in order to get the change in scores.
Outcome measures
| Measure |
Primary Group
n=10 Participants
Phase 1
|
|---|---|
|
Change in Children's Sleep Habits Questionnaire
Bedtime Resistance
|
-.4 units on a scale
Standard Deviation .7
|
|
Change in Children's Sleep Habits Questionnaire
Sleep Onset Delay
|
-.6 units on a scale
Standard Deviation .7
|
|
Change in Children's Sleep Habits Questionnaire
Sleep Duration
|
-.3 units on a scale
Standard Deviation 1.25
|
|
Change in Children's Sleep Habits Questionnaire
Sleep Anxiety
|
-.22 units on a scale
Standard Deviation 1.09
|
|
Change in Children's Sleep Habits Questionnaire
Night Wakings
|
-.33 units on a scale
Standard Deviation 1.66
|
|
Change in Children's Sleep Habits Questionnaire
Parasomnias
|
.56 units on a scale
Standard Deviation 1.13
|
|
Change in Children's Sleep Habits Questionnaire
Disordered Breathing
|
0 units on a scale
Standard Deviation 0
|
|
Change in Children's Sleep Habits Questionnaire
Daytime Sleepiness
|
-.78 units on a scale
Standard Deviation 1.99
|
|
Change in Children's Sleep Habits Questionnaire
Total Disturbance
|
-2.44 units on a scale
Standard Deviation 3.54
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SECONDARY outcome
Timeframe: Pre intervention (baseline), post intervention (8 weeks)The Parenting Stress Index (PSI) was designed for parents of children ages 1:6 to 12:5 and identifies stressors in the parent-child relationship. Specifically, the PSI measures child's characteristics on six subscales, which are summed get a total score in the child domain (47 to 235). The PSI also has seven subscales that measure parent characteristics, and are summed to get a total score in the parent domain (54 to 270). The totals from the parent and child domains are summed for a total stress score (101 to 505). Higher scores indicate a higher level of stress. Pre scores were subtracted from post scores in order to get the change in scores.
Outcome measures
| Measure |
Primary Group
n=10 Participants
Phase 1
|
|---|---|
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Change in Parenting Stress Index
Child Domain Total
|
-11.67 units on a scale
Standard Deviation 12.19
|
|
Change in Parenting Stress Index
Parent Domain Total
|
-4 units on a scale
Standard Deviation 10.74
|
|
Change in Parenting Stress Index
Total Stress
|
-15.67 units on a scale
Standard Deviation 19.72
|
Adverse Events
Primary Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place