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| Name | Class |
|---|---|
| Crisis Prevention Institute | OTHER |
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The purpose of this 24-week study is to determine whether the "Parent-based Crisis Prevention Institute (CPI) physical management training program" (i.e., P-CPI) is effective in increasing self-efficacy in parents of children with autism spectrum disorder (ASD).
Parents of children with ASD deal with more stress, especially if their child demonstrates self-injurious and aggressive behavior. The purpose of this study is to evaluate whether "Parent-based Crisis Prevention Institute (CPI) physical management training program" (i.e., P-CPI) for parents of children with ASD helps alleviate some of this stress and increase parental self-efficacy, physical management competency, and overall quality of life.
Participants who meet criteria will be randomly assigned to either the treatment group or the waitlist control group. Participants assigned to the treatment group will be invited to a 6-hour P-CPI group training session. This parent-based training in CPI's Nonviolent Crisis Intervention® will include nonverbal, paraverbal, verbal, and physical intervention techniques. Participants assigned to the waitlist group will be encouraged to continue their existing medical support, or services, as they typically would. The waitlist group will be invited to participate in the P-CPI training at the conclusion of the post-assessment period.
Baseline measures will be on the day of training for the treatment group and within five days of the P-CPI training for the waitlist group. Follow-up measures will be at 2-week, and 1, 2, and 3- month post-baseline. The treatment group will also participate in a follow-up group interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPI-Parent Training | Experimental | Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques. |
|
| Waitlist Control | No Intervention | Will not receive active P-CPI training during the experimental treatment interval. NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI) | Behavioral | Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score | The CAPES-DD self-efficacy scale is a 16-item brief outcome measure in the evaluation of individual parenting interventions that measures parents' self-efficacy in managing specific child behavior problems. Instructions were modified to ask about the previous two weeks instead of the previous four weeks. The range of possible scores is 16-160, with higher scores corresponding to greater parental self-efficacy and a positive change indicating improvement from baseline. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit. | Baseline and 2-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Parent Stress Index - Short Form Total Score | The PSI-SF is a self-report measure of severity and domain of parenting stress which includes 36 items rated on a 5-point, Likert scale. The range of possible values for the total stress raw score is 36-180, with higher scores corresponding to greater levels of parental stress and negative change corresponding to reduced levels of parental stress. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit. |
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Inclusion Criteria:
Each subject must be an adult caregiver/parent of a Lurie Center for Autism patient with 'patient' defined as having at minimum one visit/contact per year with any Lurie Center for Autism clinician. The patient (child):
The subject may have any primary language but must be comfortable speaking and reading English without translation.
The subject must be the self-identified primary caregiver of the Lurie Center for Autism patient.
The subject must be recommended by a Lurie Center for Autism clinician.
The subject must be able to attend in person the maximum the training session on the specified date/time/location.
The subject must be willing to complete the assessment measures.
Only one subject per family may participate.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Nowinski, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurie Center for Autism | Lexington | Massachusetts | 02421 | United States |
One participant withdrew consent prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPI-Parent Training | Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques. Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview. |
| FG001 | Waitlist Control | Will not receive active P-CPI training during the experimental treatment interval. NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Six participants assigned to CPI-Parent training and 11 participants assigned to waitlist discontinued study participation prior to baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | CPI-Parent Training | Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques. Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score | The CAPES-DD self-efficacy scale is a 16-item brief outcome measure in the evaluation of individual parenting interventions that measures parents' self-efficacy in managing specific child behavior problems. Instructions were modified to ask about the previous two weeks instead of the previous four weeks. The range of possible scores is 16-160, with higher scores corresponding to greater parental self-efficacy and a positive change indicating improvement from baseline. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit. | All 35 participants assigned to P-CPI training and 28 participants assigned to waitlist who completed the baseline assessment contributed at least one CAPES-DD self-efficacy total score to the analysis. Five of these participants contributed only one score: two assigned to P-CPI training and one assigned to waitlist who discontinued study participation between baseline and two weeks, and one at baseline and one at two weeks assigned to P-CPI training who provided incomplete CAPES-DD data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 2-weeks |
2 weeks
Events determined by the Principal Investigator (PI) to be unanticipated problems involving risks to participants or others were to be reported by the PI according to the Partners Human Research Committee's reporting policies.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPI-Parent Training | Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques. Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Nowinski, PhD | Massachusetts General Hospital Lurie Center | 781-860-1700 | lnowinski@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 | Apr 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
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| ID | Term |
|---|---|
| C110747 | cyclopropapyrroloindole |
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|
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| Baseline and 2-weeks |
| Change in the Family Quality of Life Scale Total Score | The FQOL is a 25-item measure assessing families' perceptions of their satisfaction with different aspects of family quality of life. It assesses five domains: family interaction, parenting, general resources, health and safety, and support for persons with disabilities. Instructions were modified to ask about the previous two weeks instead of the previous 12 months. The range of possible values for the FQOL total score is 25-125, with higher scores corresponding to better quality of life and positive change corresponding to improved quality of life. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit. | Baseline and 2-weeks |
| Did not return study questionnaires |
|
| BG001 | Waitlist Control | Will not receive active P-CPI training during the experimental treatment interval. NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score | The CAPES-DD self-efficacy scale is a 16-item brief outcome measure in the evaluation of individual parenting interventions that measures parents' self-efficacy in managing specific child behavior problems. Instructions were modified to ask about the previous two weeks instead of the previous four weeks. The range of possible scores is 16-160, with higher scores corresponding to greater parental self-efficacy. | Mean | Standard Deviation | units on a scale |
|
| Parent Stress Index - Short Form Total Score | The PSI-SF is a self-report measure of severity and domain of parenting stress which includes 36 items rated on a 5-point, Likert scale. The range of possible values for the total stress raw score is 36-180, with higher scores corresponding to greater levels of parental stress. | Mean | Standard Deviation | units on a scale |
|
| Family Quality of Life Scale Total Score | The FQOL scale is a 25-item measure assessing families' perceptions of their satisfaction with different aspects of family quality of life. It assesses five domains: family interaction, parenting, general resources, health and safety, and support for persons with disabilities. Instructions were modified to ask about the previous two weeks instead of the previous 12 months. The range of possible values for the FQOL total score is 25-125, with higher scores corresponding to better quality of life. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | CPI-Parent Training | Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques. Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview. |
| OG001 | Waitlist Control | Will not receive active P-CPI training during the experimental treatment interval. NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures. |
|
|
|
| Secondary | Change in the Parent Stress Index - Short Form Total Score | The PSI-SF is a self-report measure of severity and domain of parenting stress which includes 36 items rated on a 5-point, Likert scale. The range of possible values for the total stress raw score is 36-180, with higher scores corresponding to greater levels of parental stress and negative change corresponding to reduced levels of parental stress. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit. | All 35 participants assigned to P-CPI training and 28 participants assigned to waitlist who completed the baseline assessment contributed at least one PSI-SF total score to the analysis. Five of these participants contributed only one score: two assigned to P-CPI training and one assigned to waitlist who discontinued study participation between baseline and two weeks, and two at two weeks assigned to P-CPI training who provided incomplete PSI-SF data or did not complete the scale. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 2-weeks |
|
|
|
|
| Secondary | Change in the Family Quality of Life Scale Total Score | The FQOL is a 25-item measure assessing families' perceptions of their satisfaction with different aspects of family quality of life. It assesses five domains: family interaction, parenting, general resources, health and safety, and support for persons with disabilities. Instructions were modified to ask about the previous two weeks instead of the previous 12 months. The range of possible values for the FQOL total score is 25-125, with higher scores corresponding to better quality of life and positive change corresponding to improved quality of life. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit. | All 35 participants assigned to P-CPI training and 28 participants assigned to waitlist who completed the baseline assessment contributed at least one FQOL total score to the analysis. Four of these participants contributed only one score: two assigned to P-CPI training and one assigned to waitlist who discontinued study participation between baseline and two weeks, and one at baseline assigned to waitlist who provided incomplete FQOL data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 2-weeks |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Waitlist Control | Will not receive active P-CPI training during the experimental treatment interval. NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |