Noncompliance
Conditions
Keywords
PCIT, autism, parent training, noncompliance
Brief summary
The aim of the current proposal is to determine if the PCIT treatment manual can be successfully utilized for preschoolers with ASD and disruptive behavior (across a range of intellectual functioning levels) and to evaluate its ability to significantly decrease measures of problem behavior. It is hypothesized that the current manual will require few modifications for use with ASD and that, in comparison to a wait-list control group, families who undergo PCIT training will evidence significant gains on measures of parenting stress, child externalizing behaviors and compliance to parental requests. To address the pilot study aims, we will recruit a total of 25 families of children with ASD (ages 2.6-6.11 years) whose children are already receiving intensive, one-on-one behavioral treatment services (15-30 hours per week) but no structured parent training. Families will be randomized to either intensive services + PCIT or intensive services alone (wait list control). Assessments will be completed at baseline, mid-treatment (9 weeks post baseline), post-treatment (18 weeks after the baseline assessment) and long-term follow-up (12 weeks post-treatment). PCIT families will attend 16 weekly, one-hour coaching sessions. Both active treatment and wait-list control families will continue to receive intensive ABA services in the home or community. Control families will receive PCIT training after 18 weeks on the wait-list. The aims of the pilot study are: 1. To assess the utility of the current PCIT treatment manual with preschoolers with ASD and disruptive behavior and their parents; Hypothesis 1: The current PCIT treatment manual will be able to be utilized with families of children with ASD with only minimal modifications. Hypothesis 2: Families of children with ASD will consistently attend PCIT sessions. 2. To determine if PCIT with this population will result in an increase in appropriate parent behaviors and a subsequent decrease in targeted child behaviors (e.g., direct assessment of noncompliance, behavior rating scales). Hypothesis 3: Families receiving PCIT training will evidence statistically greater decreases on measures of disruptive behavior, quality of parent-child interactions and parental stress than families on the wait-list control group.
Detailed description
Young children with ASD often present with a range of externalizing behavior problems, including aggression, tantrums and difficulty transitioning. Interventions based on the principles of applied behavior analysis (ABA) have been shown to offer an effective means of addressing many of these concerns. Parent-Child Interaction Therapy (PCIT) is a manualized, empirically supported parent coaching intervention that has been found to be highly effective for typically developing preschoolers presenting with a range of mental health concerns. It also holds considerable promise as a potentially effective treatment for children with ASD. The focus of PCIT treatment is to both improve parent-child interactions and to reduce child behavior problems. PCIT involves the coaching of parents in real-time, via a one-way mirror and a bug-in-the ear device that allows the therapist to provide feedback and directions to the parent while interacting with his/her child. The aim of the current proposal is to determine if the PCIT treatment manual can be successfully utilized for preschoolers with ASD and to evaluate its ability to significantly decrease measures of problem behavior. It is hypothesized that the current manual will require few modifications for use with ASD and that, in comparison to a wait-list control group, families who undergo PCIT training will evidence significant gains on measures of parenting stress, child externalizing behaviors and compliance to parental requests. To address the pilot study aims, we will recruit a total of 25 families of children with ASD (ages 2.6-6 years) whose children are already receiving intensive, one-on-one behavioral treatment services (15-30 hours per week). Families will be randomized to either intensive services + PCIT or intensive services alone (wait list control). Assessments will be completed at baseline, mid-treatment (9 weeks post baseline) and post-treatment (18 weeks after the baseline assessment). PCIT families will attend 20 weekly, one-hour coaching sessions. Both active treatment and wait-list control families will continue to receive intensive ABA services in the home or community. The results of this study will provide pilot data in a subsequent application for federal funding to conduct larger controlled trials, including examining the use of PCIT in school-age children with ASD and intellectual disability and to assess the individual and combined efficacy of PCIT and psychopharmacological treatment.
Interventions
BEHAVIORALParent 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.
Sponsors
Autism Speaks
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Months to 83 Months
Healthy volunteers
No
Inclusion criteria
i. Outpatients between 2 years, 6 months and 6 years, 11 months of age; ii. Diagnosis of Autistic Disorder, Pervasive Developmental Disorder Not Otherwise Specified, or Asperger's Disorder based upon the Autism Diagnostic Observation Schedule and clinical evaluation by Diagnostic and Statistical Manual of Mental Disorders IV criteria; iii. Males and females; iv. Mental Age\>30 months based upon the Stanford-Binet V or Mullens \[to insure that the child possesses enough expressive language to offer opportunities for the parent to learn verbal reflection skills and that child is able to understand time out\]; v. Eyberg Child Behavior Inventory score greater than or equal to 120; vi. Behavior Assessment System for Children Externalizing Problem Scale T-score \>65; vii. Care provider who can reliably bring subject to clinic visits, can attend weekly PCIT sessions, can provide trustworthy ratings and interact with subject on a regular basis.
Exclusion criteria
i. Unstable use of psychotropic medications (no changes in dose for at least two months and no plans to change dose during the course of the study); ii. Unstable use of dietary supplements (e.g., casein-gluten free diet)(no changes in supplement dose for at least two months and no plans to change douse during the course of the study); iii. Prior involvement in PCIT or currently receiving parent training. iv. Extremely severe behavioral concerns that require immediate treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eyberg Child Behavior Inventory | Week 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Stress Index-4 Short Form | Week 18 | 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. |
| Social Responsiveness Scale 2 Score | Week 9 | 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. |
| Dyadic Parent-Child Interaction Coding System Scores | Week 9 | 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. |
| Parental Stress Index Score | Week 9 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 13 |
| Wait List Control Families will wait 18 weeks for treatment, serving as controls. | 10 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | Parent Child Interaction Therapy | Total | Wait List Control |
|---|---|---|---|
| Age, Continuous | 63.62 months STANDARD_DEVIATION 17.08 | 65.087 months STANDARD_DEVIATION 16.45631 | 67.0 months STANDARD_DEVIATION 16.31 |
| Dyadic Parent-Child Interaction Coding Negative Skills | 73.92 Frequency of Behavior STANDARD_DEVIATION 21.66 | 84.45 Frequency of Behavior STANDARD_DEVIATION 26.68 | 97.10 Frequency of Behavior STANDARD_DEVIATION 27.6 |
| Dyadic Parent-Child Interaction Coding Positive Skills | 6.67 Frequency of Behavior STANDARD_DEVIATION 4.23 | 7.41 Frequency of Behavior STANDARD_DEVIATION 5.11 | 8.30 Frequency of Behavior STANDARD_DEVIATION 6.13 |
| Eyberg Child Behavior Inventory Intensity | 166.00 units on a scale STANDARD_DEVIATION 29.8 | 162.22 units on a scale STANDARD_DEVIATION 26.1 | 157.30 units on a scale STANDARD_DEVIATION 21 |
| Eyberg Child Behavior Inventory Problem | 19.46 units on a scale STANDARD_DEVIATION 8.56 | 19.70 units on a scale STANDARD_DEVIATION 7.29 | 20.00 units on a scale STANDARD_DEVIATION 5.66 |
| Intelligence Quotient (IQ) | 93.38 units on a scale STANDARD_DEVIATION 15.68 | 97.83 units on a scale STANDARD_DEVIATION 19.02 | 103.60 units on a scale STANDARD_DEVIATION 21.29 |
| Parental Stress Index Difficult Child Subscale Score | 43.15 units on a scale STANDARD_DEVIATION 5.71 | 42.13 units on a scale STANDARD_DEVIATION 6.19 | 40.80 units on a scale STANDARD_DEVIATION 6.83 |
| Parental Stress Index Parent-Child Dysfunctional Interaction Subscale Sc | 32.54 units on a scale STANDARD_DEVIATION 7.58 | 30.91 units on a scale STANDARD_DEVIATION 8.11 | 28.80 units on a scale STANDARD_DEVIATION 8.68 |
| Parental Stress Index Parent Distress Subscale Score | 32.31 units on a scale STANDARD_DEVIATION 9.38 | 31.87 units on a scale STANDARD_DEVIATION 9.56 | 31.30 units on a scale STANDARD_DEVIATION 10.25 |
| Parental Stress Index PSI Defensive Responding | 19.62 units on a scale STANDARD_DEVIATION 5.55 | 19.48 units on a scale STANDARD_DEVIATION 6.01 | 19.30 units on a scale STANDARD_DEVIATION 6.88 |
| Parental Stress Index Total Stress | 108.00 units on a scale STANDARD_DEVIATION 18.75 | 104.96 units on a scale STANDARD_DEVIATION 20.2 | 101.00 units on a scale STANDARD_DEVIATION 22.32 |
| Peabody Picture Vocabulary Test | 97.83 units on a scale STANDARD_DEVIATION 13.27 | 101.18 units on a scale STANDARD_DEVIATION 14.81 | 105.20 units on a scale STANDARD_DEVIATION 16.24 |
| Race/Ethnicity, Customized African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 11 Participants | 21 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Mixed Race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 12 Participants | 21 Participants | 9 Participants |
| Social Responsiveness Scale 2 SRS Awareness Raw Score | 13.62 units on a scale STANDARD_DEVIATION 2.75 | 13.00 units on a scale STANDARD_DEVIATION 3.23 | 12.20 units on a scale STANDARD_DEVIATION 3.77 |
| Social Responsiveness Scale 2 SRS Cognition Raw Score | 17.92 units on a scale STANDARD_DEVIATION 5.96 | 16.70 units on a scale STANDARD_DEVIATION 5.16 | 15.10 units on a scale STANDARD_DEVIATION 3.54 |
| Social Responsiveness Scale 2 SRS Communication Raw Score | 32.15 units on a scale STANDARD_DEVIATION 10.47 | 31.39 units on a scale STANDARD_DEVIATION 9.27 | 30.40 units on a scale STANDARD_DEVIATION 7.86 |
| Social Responsiveness Scale 2 SRS Motivation Raw Score | 16.38 units on a scale STANDARD_DEVIATION 4.86 | 14.57 units on a scale STANDARD_DEVIATION 4.78 | 12.20 units on a scale STANDARD_DEVIATION 3.68 |
| Social Responsiveness Scale 2 SRS Restricted and Repetitive Behaviors Raw Score | 19.00 units on a scale STANDARD_DEVIATION 7.44 | 18.74 units on a scale STANDARD_DEVIATION 7.12 | 18.40 units on a scale STANDARD_DEVIATION 7.07 |
| Social Responsiveness Scale 2 SRS Total Raw Score | 99.08 units on a scale STANDARD_DEVIATION 24.65 | 94.39 units on a scale STANDARD_DEVIATION 23.55 | 88.30 units on a scale STANDARD_DEVIATION 21.74 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 |
| other Total, other adverse events | 0 / 13 | 0 / 10 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 |
Outcome results
Primary
Eyberg Child Behavior Inventory
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.
Time frame: Week 18
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Child Interaction Therapy | Eyberg Child Behavior Inventory | ECBI Intensity Score | 115.20 units on a scale | Standard Deviation 41.54 |
| Parent Child Interaction Therapy | Eyberg Child Behavior Inventory | ECBI Problem Score | 14.10 units on a scale | Standard Deviation 10.54 |
| Wait List Control | Eyberg Child Behavior Inventory | ECBI Intensity Score | 148.67 units on a scale | Standard Deviation 25.25 |
| Wait List Control | Eyberg Child Behavior Inventory | ECBI Problem Score | 19.67 units on a scale | Standard Deviation 5 |
Comparison: Comparison of ECBI Problem Score between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.08Wilcoxon (Mann-Whitney)
Comparison: Comparison of ECBI Intensity Score between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.026t-test, 1 sided
Comparison: Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.p-value: 0.182Mixed Models Analysis
Comparison: Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.p-value: 0.015Mixed Models Analysis
Primary
Eyberg Child Behavior Inventory
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.
Time frame: Week 9
Population: Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Child Interaction Therapy | Eyberg Child Behavior Inventory | ECBI Problem Score | 18.9 units on a scale | Standard Deviation 9.65 |
| Parent Child Interaction Therapy | Eyberg Child Behavior Inventory | ECBI Intensity Score | 132.50 units on a scale | Standard Deviation 42.62 |
| Wait List Control | Eyberg Child Behavior Inventory | ECBI Problem Score | 19.11 units on a scale | Standard Deviation 6.45 |
| Wait List Control | Eyberg Child Behavior Inventory | ECBI Intensity Score | 154.33 units on a scale | Standard Deviation 25.6 |
Secondary
Dyadic Parent-Child Interaction Coding System Scores
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.
Time frame: Week 9
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Child Interaction Therapy | Dyadic Parent-Child Interaction Coding System Scores | Negative Skills | 35.2 frequency of behaviors | Standard Deviation 14.54 |
| Parent Child Interaction Therapy | Dyadic Parent-Child Interaction Coding System Scores | Positive Skills | 26.9 frequency of behaviors | Standard Deviation 16.28 |
| Wait List Control | Dyadic Parent-Child Interaction Coding System Scores | Negative Skills | 81.78 frequency of behaviors | Standard Deviation 19.886 |
| Wait List Control | Dyadic Parent-Child Interaction Coding System Scores | Positive Skills | 5.667 frequency of behaviors | Standard Deviation 5 |
Secondary
Dyadic Parent-Child Interaction Coding System Scores
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.
Time frame: Week 18
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Child Interaction Therapy | Dyadic Parent-Child Interaction Coding System Scores | Negative Skills | 22.2 counts of behaviors | Standard Deviation 14.71 |
| Parent Child Interaction Therapy | Dyadic Parent-Child Interaction Coding System Scores | Positive Skills | 41.4 counts of behaviors | Standard Deviation 23.98 |
| Wait List Control | Dyadic Parent-Child Interaction Coding System Scores | Negative Skills | 76.44 counts of behaviors | Standard Deviation 24.6 |
| Wait List Control | Dyadic Parent-Child Interaction Coding System Scores | Positive Skills | 8.11 counts of behaviors | Standard Deviation 6.29 |
Comparison: Comparison of DPICS Negative Skills between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Comparison of DPICS Positive Skills between Week 18 scores, 1 sided test for Treatment Group Superiority. Data transformed using a square root transformation.p-value: <0.001t-test, 1 sided
Secondary
Parental Stress Index-4 Short Form
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.
Time frame: Week 18
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Child Interaction Therapy | Parental Stress Index-4 Short Form | Parent Distress Subscale Score | 29.10 units on a scale | Standard Deviation 12.28 |
| Parent Child Interaction Therapy | Parental Stress Index-4 Short Form | Difficult Child Subscale Score | 38.20 units on a scale | Standard Deviation 12.59 |
| Parent Child Interaction Therapy | Parental Stress Index-4 Short Form | Parent-Child Dysfunctional Interaction Subscale | 28.80 units on a scale | Standard Deviation 7.98 |
| Parent Child Interaction Therapy | Parental Stress Index-4 Short Form | Total Stress | 96.10 units on a scale | Standard Deviation 28.67 |
| Parent Child Interaction Therapy | Parental Stress Index-4 Short Form | PSI Defensive Responding | 17.70 units on a scale | Standard Deviation 7.21 |
| Wait List Control | Parental Stress Index-4 Short Form | Total Stress | 104.56 units on a scale | Standard Deviation 18.21 |
| Wait List Control | Parental Stress Index-4 Short Form | PSI Defensive Responding | 20.33 units on a scale | Standard Deviation 4.77 |
| Wait List Control | Parental Stress Index-4 Short Form | Parent Distress Subscale Score | 33.44 units on a scale | Standard Deviation 9.53 |
| Wait List Control | Parental Stress Index-4 Short Form | Parent-Child Dysfunctional Interaction Subscale | 27.44 units on a scale | Standard Deviation 7.32 |
| Wait List Control | Parental Stress Index-4 Short Form | Difficult Child Subscale Score | 43.56 units on a scale | Standard Deviation 5.5 |
Comparison: Comparison of PSI Parental Distress between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.203t-test, 1 sided
Comparison: Comparison of PSI Parent-Child Dysfunctional Interaction between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.17Wilcoxon (Mann-Whitney)
Comparison: Comparison of PSI Difficult Child between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.308t-test, 1 sided
Comparison: Comparison of PSI Total Score between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.413Wilcoxon (Mann-Whitney)
Secondary
Parental Stress Index Score
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.
Time frame: Week 9
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Child Interaction Therapy | Parental Stress Index Score | Parent-Child Dysfunctional Interaction Subscale Sc | 31.30 units on a scale | Standard Deviation 9.26 |
| Parent Child Interaction Therapy | Parental Stress Index Score | Difficult Child Subscale Score | 41.30 units on a scale | Standard Deviation 10.67 |
| Parent Child Interaction Therapy | Parental Stress Index Score | Parent Distress Subscale Score | 31.30 units on a scale | Standard Deviation 11.2 |
| Parent Child Interaction Therapy | Parental Stress Index Score | Total Stress | 103.90 units on a scale | Standard Deviation 28.18 |
| Parent Child Interaction Therapy | Parental Stress Index Score | PSI DR | 18.80 units on a scale | Standard Deviation 7.15 |
| Wait List Control | Parental Stress Index Score | Difficult Child Subscale Score | 41.11 units on a scale | Standard Deviation 8.45 |
| Wait List Control | Parental Stress Index Score | Parent-Child Dysfunctional Interaction Subscale Sc | 28.78 units on a scale | Standard Deviation 11.65 |
| Wait List Control | Parental Stress Index Score | Total Stress | 101.33 units on a scale | Standard Deviation 24.77 |
| Wait List Control | Parental Stress Index Score | PSI DR | 19.56 units on a scale | Standard Deviation 5.41 |
| Wait List Control | Parental Stress Index Score | Parent Distress Subscale Score | 31.44 units on a scale | Standard Deviation 8.93 |
Secondary
Social Responsiveness Scale 2 Score
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.
Time frame: Week 18
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Total Raw Score | 80.00 units on a scale | Standard Deviation 28.25 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Awareness Raw Score | 12.40 units on a scale | Standard Deviation 2.67 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Cognition Raw Score | 14.60 units on a scale | Standard Deviation 5.97 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Communication Raw Score | 27.10 units on a scale | Standard Deviation 10.26 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Motivation Raw Score | 11.10 units on a scale | Standard Deviation 5.38 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Restricted and Repetitive Behaviors Raw Score | 14.80 units on a scale | Standard Deviation 8.38 |
| Wait List Control | Social Responsiveness Scale 2 Score | Restricted and Repetitive Behaviors Raw Score | 18.11 units on a scale | Standard Deviation 8.54 |
| Wait List Control | Social Responsiveness Scale 2 Score | Total Raw Score | 88.22 units on a scale | Standard Deviation 29.12 |
| Wait List Control | Social Responsiveness Scale 2 Score | Communication Raw Score | 30.67 units on a scale | Standard Deviation 11.25 |
| Wait List Control | Social Responsiveness Scale 2 Score | Awareness Raw Score | 12.11 units on a scale | Standard Deviation 4.65 |
| Wait List Control | Social Responsiveness Scale 2 Score | Motivation Raw Score | 11.44 units on a scale | Standard Deviation 4.59 |
| Wait List Control | Social Responsiveness Scale 2 Score | Cognition Raw Score | 15.89 units on a scale | Standard Deviation 4.08 |
Comparison: Comparison of SRS Total Score between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.271t-test, 1 sided
Comparison: Comparison of SRS Awareness Score between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.434t-test, 1 sided
Comparison: Comparison of SRS Cognition Scores between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.298t-test, 1 sided
Comparison: Comparison of SRS Communication Score between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.294t-test, 1 sided
Comparison: Comparison of SRS Motivation between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.441t-test, 1 sided
Comparison: Comparison of SRS Restricted and Repetitive Behavior Score between Week 18 scores, 1 sided test for Treatment Group Superiorityp-value: 0.204t-test, 1 sided
Secondary
Social Responsiveness Scale 2 Score
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.
Time frame: Week 9
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Total Raw Score | 91.20 units on a scale | Standard Deviation 34.31 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Awareness Raw Score | 13.20 units on a scale | Standard Deviation 3.19 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Cognition Raw Score | 15.80 units on a scale | Standard Deviation 7.3 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Communication Raw Score | 30.80 units on a scale | Standard Deviation 13.31 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Motivation Raw Score | 14.40 units on a scale | Standard Deviation 5.74 |
| Parent Child Interaction Therapy | Social Responsiveness Scale 2 Score | Restricted and Repetitive Behaviors Raw Score | 17.00 units on a scale | Standard Deviation 8.71 |
| Wait List Control | Social Responsiveness Scale 2 Score | Motivation Raw Score | 12.22 units on a scale | Standard Deviation 3.38 |
| Wait List Control | Social Responsiveness Scale 2 Score | Total Raw Score | 92.22 units on a scale | Standard Deviation 17.65 |
| Wait List Control | Social Responsiveness Scale 2 Score | Communication Raw Score | 32.78 units on a scale | Standard Deviation 7.58 |
| Wait List Control | Social Responsiveness Scale 2 Score | Awareness Raw Score | 12.78 units on a scale | Standard Deviation 2.11 |
| Wait List Control | Social Responsiveness Scale 2 Score | Restricted and Repetitive Behaviors Raw Score | 18.44 units on a scale | Standard Deviation 7.21 |
| Wait List Control | Social Responsiveness Scale 2 Score | Cognition Raw Score | 16.00 units on a scale | Standard Deviation 3.04 |