Trial Outcomes & Findings for Efficacy of Parent-Child Interaction Therapy With Autism Spectrum Disorder (NCT NCT02088905)
NCT ID: NCT02088905
Last Updated: 2019-03-22
Results Overview
Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 9. The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always). Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors. The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no). Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors.
COMPLETED
NA
25 participants
Week 9
2019-03-22
Participant Flow
Recruitment began June 2014, with clinicians at the Merck Center for Autism and Developmental Disorders or from the Child Development Unit bringing up the study to patients. 140 subjects were excluded during phone screen. 77 did not meet inclusion criteria, 39 declined consent due to high burden of time/procedures, 24 refused for other reasons.
Two subjects of the originally enrolled 25 were discovered to have not met inclusion criteria. Upon the discovery, they were removed from the study and not randomized to any study condition.
Participant milestones
| Measure |
Parent Child Interaction Therapy
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
Week 9
|
10
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Parent Child Interaction Therapy
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
Baseline Characteristics
Missing data for one participant
Baseline characteristics by cohort
| Measure |
Parent Child Interaction Therapy
n=13 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with Autism Spectrum Disorder because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
n=10 Participants
Families will wait 18 weeks for treatment, serving as controls.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.62 months
STANDARD_DEVIATION 17.08 • n=13 Participants
|
67.0 months
STANDARD_DEVIATION 16.31 • n=10 Participants
|
65.087 months
STANDARD_DEVIATION 16.45631 • n=23 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=13 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=13 Participants
|
9 Participants
n=10 Participants
|
21 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 Participants
n=13 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Peabody Picture Vocabulary Test
|
97.83 units on a scale
STANDARD_DEVIATION 13.27 • n=12 Participants • Missing data for one participant
|
105.20 units on a scale
STANDARD_DEVIATION 16.24 • n=10 Participants • Missing data for one participant
|
101.18 units on a scale
STANDARD_DEVIATION 14.81 • n=22 Participants • Missing data for one participant
|
|
Intelligence Quotient (IQ)
|
93.38 units on a scale
STANDARD_DEVIATION 15.68 • n=13 Participants
|
103.60 units on a scale
STANDARD_DEVIATION 21.29 • n=10 Participants
|
97.83 units on a scale
STANDARD_DEVIATION 19.02 • n=23 Participants
|
|
Parental Stress Index
PSI Defensive Responding
|
19.62 units on a scale
STANDARD_DEVIATION 5.55 • n=13 Participants
|
19.30 units on a scale
STANDARD_DEVIATION 6.88 • n=10 Participants
|
19.48 units on a scale
STANDARD_DEVIATION 6.01 • n=23 Participants
|
|
Parental Stress Index
Parent Distress Subscale Score
|
32.31 units on a scale
STANDARD_DEVIATION 9.38 • n=13 Participants
|
31.30 units on a scale
STANDARD_DEVIATION 10.25 • n=10 Participants
|
31.87 units on a scale
STANDARD_DEVIATION 9.56 • n=23 Participants
|
|
Parental Stress Index
Parent-Child Dysfunctional Interaction Subscale Sc
|
32.54 units on a scale
STANDARD_DEVIATION 7.58 • n=13 Participants
|
28.80 units on a scale
STANDARD_DEVIATION 8.68 • n=10 Participants
|
30.91 units on a scale
STANDARD_DEVIATION 8.11 • n=23 Participants
|
|
Parental Stress Index
Difficult Child Subscale Score
|
43.15 units on a scale
STANDARD_DEVIATION 5.71 • n=13 Participants
|
40.80 units on a scale
STANDARD_DEVIATION 6.83 • n=10 Participants
|
42.13 units on a scale
STANDARD_DEVIATION 6.19 • n=23 Participants
|
|
Parental Stress Index
Total Stress
|
108.00 units on a scale
STANDARD_DEVIATION 18.75 • n=13 Participants
|
101.00 units on a scale
STANDARD_DEVIATION 22.32 • n=10 Participants
|
104.96 units on a scale
STANDARD_DEVIATION 20.20 • n=23 Participants
|
|
Eyberg Child Behavior Inventory
Intensity
|
166.00 units on a scale
STANDARD_DEVIATION 29.8 • n=13 Participants
|
157.30 units on a scale
STANDARD_DEVIATION 21.0 • n=10 Participants
|
162.22 units on a scale
STANDARD_DEVIATION 26.1 • n=23 Participants
|
|
Eyberg Child Behavior Inventory
Problem
|
19.46 units on a scale
STANDARD_DEVIATION 8.56 • n=13 Participants
|
20.00 units on a scale
STANDARD_DEVIATION 5.66 • n=10 Participants
|
19.70 units on a scale
STANDARD_DEVIATION 7.29 • n=23 Participants
|
|
Dyadic Parent-Child Interaction Coding
Positive Skills
|
6.67 Frequency of Behavior
STANDARD_DEVIATION 4.23 • n=12 Participants • Data missing for one participant
|
8.30 Frequency of Behavior
STANDARD_DEVIATION 6.13 • n=10 Participants • Data missing for one participant
|
7.41 Frequency of Behavior
STANDARD_DEVIATION 5.11 • n=22 Participants • Data missing for one participant
|
|
Dyadic Parent-Child Interaction Coding
Negative Skills
|
73.92 Frequency of Behavior
STANDARD_DEVIATION 21.66 • n=12 Participants • Data missing for one participant
|
97.10 Frequency of Behavior
STANDARD_DEVIATION 27.60 • n=10 Participants • Data missing for one participant
|
84.45 Frequency of Behavior
STANDARD_DEVIATION 26.68 • n=22 Participants • Data missing for one participant
|
|
Social Responsiveness Scale 2
SRS Total Raw Score
|
99.08 units on a scale
STANDARD_DEVIATION 24.65 • n=13 Participants
|
88.30 units on a scale
STANDARD_DEVIATION 21.74 • n=10 Participants
|
94.39 units on a scale
STANDARD_DEVIATION 23.55 • n=23 Participants
|
|
Social Responsiveness Scale 2
SRS Awareness Raw Score
|
13.62 units on a scale
STANDARD_DEVIATION 2.75 • n=13 Participants
|
12.20 units on a scale
STANDARD_DEVIATION 3.77 • n=10 Participants
|
13.00 units on a scale
STANDARD_DEVIATION 3.23 • n=23 Participants
|
|
Social Responsiveness Scale 2
SRS Cognition Raw Score
|
17.92 units on a scale
STANDARD_DEVIATION 5.96 • n=13 Participants
|
15.10 units on a scale
STANDARD_DEVIATION 3.54 • n=10 Participants
|
16.70 units on a scale
STANDARD_DEVIATION 5.16 • n=23 Participants
|
|
Social Responsiveness Scale 2
SRS Communication Raw Score
|
32.15 units on a scale
STANDARD_DEVIATION 10.47 • n=13 Participants
|
30.40 units on a scale
STANDARD_DEVIATION 7.86 • n=10 Participants
|
31.39 units on a scale
STANDARD_DEVIATION 9.27 • n=23 Participants
|
|
Social Responsiveness Scale 2
SRS Motivation Raw Score
|
16.38 units on a scale
STANDARD_DEVIATION 4.86 • n=13 Participants
|
12.20 units on a scale
STANDARD_DEVIATION 3.68 • n=10 Participants
|
14.57 units on a scale
STANDARD_DEVIATION 4.78 • n=23 Participants
|
|
Social Responsiveness Scale 2
SRS Restricted and Repetitive Behaviors Raw Score
|
19.00 units on a scale
STANDARD_DEVIATION 7.44 • n=13 Participants
|
18.40 units on a scale
STANDARD_DEVIATION 7.07 • n=10 Participants
|
18.74 units on a scale
STANDARD_DEVIATION 7.12 • n=23 Participants
|
PRIMARY outcome
Timeframe: Week 9Population: Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 9. The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always). Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors. The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no). Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors.
Outcome measures
| Measure |
Parent Child Interaction Therapy
n=10 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
n=9 Participants
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Eyberg Child Behavior Inventory
ECBI Intensity Score
|
132.50 units on a scale
Standard Deviation 42.62
|
154.33 units on a scale
Standard Deviation 25.60
|
|
Eyberg Child Behavior Inventory
ECBI Problem Score
|
18.9 units on a scale
Standard Deviation 9.65
|
19.11 units on a scale
Standard Deviation 6.45
|
PRIMARY outcome
Timeframe: Week 18Population: Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 18 The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always). Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors. The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no). Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors.
Outcome measures
| Measure |
Parent Child Interaction Therapy
n=10 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
n=9 Participants
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Eyberg Child Behavior Inventory
ECBI Intensity Score
|
115.20 units on a scale
Standard Deviation 41.54
|
148.67 units on a scale
Standard Deviation 25.25
|
|
Eyberg Child Behavior Inventory
ECBI Problem Score
|
14.10 units on a scale
Standard Deviation 10.54
|
19.67 units on a scale
Standard Deviation 5.00
|
SECONDARY outcome
Timeframe: Week 18Population: Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Parental Stress Index-4 Short Form (PSI) is comprised of several subscales that are independently measured and also combined to create a total score. Scores are calculated from 36 questions that rated as Strongly Agree/Agree/Not Sure/Disagree/Strongly Disagree by the parents. Ratings are attached to a 5-point Likert scale. PSI Defensive Responding subscale range: 7-35. Lower scores indicate higher defensive responding from parents. For the PSI Parental Distress subscale, range 12-60. Higher scores indicate higher parental stress in the parenting. For the PSI Parent-Child Dysfunctional Interaction subscale, range 12-60. Higher scores indicate parents feel their child is not meeting their expectations when interacting. For the PSI Difficult Child subscale, range 12-60. Higher scores indicates parents view their child to be difficult to parent. For PSI Total Stress, range 43-215. Higher scores indicate higher stress.
Outcome measures
| Measure |
Parent Child Interaction Therapy
n=10 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
n=9 Participants
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Parental Stress Index-4 Short Form
PSI Defensive Responding
|
17.70 units on a scale
Standard Deviation 7.21
|
20.33 units on a scale
Standard Deviation 4.77
|
|
Parental Stress Index-4 Short Form
Parent Distress Subscale Score
|
29.10 units on a scale
Standard Deviation 12.28
|
33.44 units on a scale
Standard Deviation 9.53
|
|
Parental Stress Index-4 Short Form
Parent-Child Dysfunctional Interaction Subscale
|
28.80 units on a scale
Standard Deviation 7.98
|
27.44 units on a scale
Standard Deviation 7.32
|
|
Parental Stress Index-4 Short Form
Difficult Child Subscale Score
|
38.20 units on a scale
Standard Deviation 12.59
|
43.56 units on a scale
Standard Deviation 5.50
|
|
Parental Stress Index-4 Short Form
Total Stress
|
96.10 units on a scale
Standard Deviation 28.67
|
104.56 units on a scale
Standard Deviation 18.21
|
SECONDARY outcome
Timeframe: Week 9Population: Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, higher scores mean more impairment. Range 0-195. Social Awareness measures social awareness impairment, higher scores mean more impairment. Range 0-24. Social Cognition measures social cognition impairment, higher scores mean more impairment. Range 0-36. Social Communication measures social communication impairment, higher scores mean more impairment. Range 0-66. Social Motivation measures social motivation impairment, higher scores means more impairment. Range 0 - 33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, with higher scores indicating more impairment. Range 0 - 36.
Outcome measures
| Measure |
Parent Child Interaction Therapy
n=10 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
n=9 Participants
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Social Responsiveness Scale 2 Score
Total Raw Score
|
91.20 units on a scale
Standard Deviation 34.31
|
92.22 units on a scale
Standard Deviation 17.65
|
|
Social Responsiveness Scale 2 Score
Awareness Raw Score
|
13.20 units on a scale
Standard Deviation 3.19
|
12.78 units on a scale
Standard Deviation 2.11
|
|
Social Responsiveness Scale 2 Score
Cognition Raw Score
|
15.80 units on a scale
Standard Deviation 7.30
|
16.00 units on a scale
Standard Deviation 3.04
|
|
Social Responsiveness Scale 2 Score
Communication Raw Score
|
30.80 units on a scale
Standard Deviation 13.31
|
32.78 units on a scale
Standard Deviation 7.58
|
|
Social Responsiveness Scale 2 Score
Motivation Raw Score
|
14.40 units on a scale
Standard Deviation 5.74
|
12.22 units on a scale
Standard Deviation 3.38
|
|
Social Responsiveness Scale 2 Score
Restricted and Repetitive Behaviors Raw Score
|
17.00 units on a scale
Standard Deviation 8.71
|
18.44 units on a scale
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: Week 18Population: Data missing from some participants. Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, higher scores mean more impairment. Range 0-195. Social Awareness measures social awareness impairment, higher scores mean more impairment. Range 0-24. Social Cognition measures social cognition impairment, higher scores mean more impairment. Range 0-36. Social Communication measures social communication impairment, higher scores mean more impairment. Range 0-66. Social Motivation measures social motivation impairment, higher scores means more impairment. Range 0 - 33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, with higher scores indicating more impairment. Range 0 - 36.
Outcome measures
| Measure |
Parent Child Interaction Therapy
n=10 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
n=9 Participants
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Social Responsiveness Scale 2 Score
Total Raw Score
|
80.00 units on a scale
Standard Deviation 28.25
|
88.22 units on a scale
Standard Deviation 29.12
|
|
Social Responsiveness Scale 2 Score
Awareness Raw Score
|
12.40 units on a scale
Standard Deviation 2.67
|
12.11 units on a scale
Standard Deviation 4.65
|
|
Social Responsiveness Scale 2 Score
Cognition Raw Score
|
14.60 units on a scale
Standard Deviation 5.97
|
15.89 units on a scale
Standard Deviation 4.08
|
|
Social Responsiveness Scale 2 Score
Communication Raw Score
|
27.10 units on a scale
Standard Deviation 10.26
|
30.67 units on a scale
Standard Deviation 11.25
|
|
Social Responsiveness Scale 2 Score
Motivation Raw Score
|
11.10 units on a scale
Standard Deviation 5.38
|
11.44 units on a scale
Standard Deviation 4.59
|
|
Social Responsiveness Scale 2 Score
Restricted and Repetitive Behaviors Raw Score
|
14.80 units on a scale
Standard Deviation 8.38
|
18.11 units on a scale
Standard Deviation 8.54
|
SECONDARY outcome
Timeframe: Week 9Population: Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child-lead play, then parent-lead play, and then clean-up. Positive Skills score is the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions. Negative skills score is a combination of the total frequency of questions, negative talk, and indirect commands throughout all conditions, as well as direct commands during child lead play. It was expected that parents would give commands during parent-lead play or clean-up.
Outcome measures
| Measure |
Parent Child Interaction Therapy
n=10 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
n=9 Participants
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Dyadic Parent-Child Interaction Coding System Scores
Negative Skills
|
35.2 frequency of behaviors
Standard Deviation 14.54
|
81.78 frequency of behaviors
Standard Deviation 19.886
|
|
Dyadic Parent-Child Interaction Coding System Scores
Positive Skills
|
26.9 frequency of behaviors
Standard Deviation 16.28
|
5.667 frequency of behaviors
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Week 18Population: Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child lead play, then parent lead play, and then clean-up. Positive Skills score was the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions. Negative skills score was a combination of the total frequency of questions, negative talk, and indirect commands throughout all conditions, as well as direct commands during child lead play. It was expected that parents would give commands during parent-lead play or clean-up.
Outcome measures
| Measure |
Parent Child Interaction Therapy
n=10 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
|
Wait List Control
n=9 Participants
Families will wait 18 weeks for treatment, serving as controls.
|
|---|---|---|
|
Dyadic Parent-Child Interaction Coding System Scores
Negative Skills
|
22.2 counts of behaviors
Standard Deviation 14.71
|
76.44 counts of behaviors
Standard Deviation 24.6
|
|
Dyadic Parent-Child Interaction Coding System Scores
Positive Skills
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41.4 counts of behaviors
Standard Deviation 23.98
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8.11 counts of behaviors
Standard Deviation 6.29
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SECONDARY outcome
Timeframe: Week 9Population: Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
Parental Stress Index-4 Short Form (PSI):Total Stress Scale, total of subscales, range 36-180, higher indicating more parental stress. Defensive Responding, range 7-35. Lower scores indicate higher defensive responding from parents. Parental Distress, range 12-60. Higher scores indicate more parental stress. Parent-Child Dysfunctional Interaction subscale, range 12-60. Higher scores indicate parents feel their child is not meeting their expectations when interacting. Difficult Child, range is 12-60. Higher scores indicate that parents view their child to be difficult to parent.
Outcome measures
| Measure |
Parent Child Interaction Therapy
n=10 Participants
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
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Wait List Control
n=9 Participants
Families will wait 18 weeks for treatment, serving as controls.
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|---|---|---|
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Parental Stress Index Score
PSI DR
|
18.80 units on a scale
Standard Deviation 7.15
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19.56 units on a scale
Standard Deviation 5.41
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Parental Stress Index Score
Parent Distress Subscale Score
|
31.30 units on a scale
Standard Deviation 11.20
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31.44 units on a scale
Standard Deviation 8.93
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Parental Stress Index Score
Parent-Child Dysfunctional Interaction Subscale Sc
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31.30 units on a scale
Standard Deviation 9.26
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28.78 units on a scale
Standard Deviation 11.65
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Parental Stress Index Score
Difficult Child Subscale Score
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41.30 units on a scale
Standard Deviation 10.67
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41.11 units on a scale
Standard Deviation 8.45
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Parental Stress Index Score
Total Stress
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103.90 units on a scale
Standard Deviation 28.18
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101.33 units on a scale
Standard Deviation 24.77
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Adverse Events
Parent Child Interaction Therapy
Wait List Control
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