Autism Spectrum DisorderNCT03537261
CPI Training for Parents of Children With ASD
A study testing Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI) in people with Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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):
- May be male or female.
- Must be from 5-12 years of age (inclusive).
- Must live at home.
- May have any IQ.
- Must have an ASD diagnosis per the DSM-5 checklist confirmed by expert clinician at enrollment.
Show all 13Show fewer
- Must have a symptom severity score of 18 or greater on the ABC Irritability subscale confirmed by expert clinician at enrollment.
- 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.
Who cannot join
- The subject must not have any self-identified physical limitations or disabilities that prevent use of physical intervention techniques.
- The patient (child) of the subject must not have any compromising neurological disorders (i.e., CP, active seizures).
- The patient should not have the addition of non-drug treatment (including ABA and parent-training) for 4 weeks prior to intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Lurie Center for Autism
Lexington, Massachusetts, 02421
About this study
Official title: Crisis Prevention Institute (CPI) Verbal and Physical Management Training for Parents of Children With ASD (P-CPI)
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).
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)
- Keywords
- Parent Training, Aggressive Behavior
- Medical subject headings
- Autism Spectrum Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)Behavioural
Also called (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2-weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start8 Aug 2018
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Crisis Prevention Institute
- Responsible party
- Principal investigator, Lisa A. Nowinski, PhD, Massachusetts General Hospital
- Investigators
- Lisa Nowinski, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537261
- Sponsor's protocol ID
- 2018P000119
- Status last verified
- Jun 2021
- First submitted
- 15 May 2018
- Last updated
- 29 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crisis Prevention Institute (CPI) Verbal and Physical Management Training for Parents of Children With ASD (P-CPI)
- ClinicalTrials.gov ID
- NCT03537261
- Acronym / sponsor ID
- 2018P000119
- Conditions
- Autism Spectrum Disorder
- Keywords
- Parent Training, Aggressive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Crisis Prevention Institute
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPI-Parent Training | Experimental | Behavioral: Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (3 listed)
- The subject must not have any self-identified physical limitations or disabilities that prevent use of physical intervention techniques.
- The patient (child) of the subject must not have any compromising neurological disorders (i.e., CP, active seizures).
- The patient should not have the addition of non-drug treatment (including ABA and parent-training) for 4 weeks prior to intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)Also: (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. | Behavioural | CPI-Parent Training |
Primary outcome
Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score
Time frame: Baseline and 2-weeks
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.
2 secondary outcomes
Change in the Parent Stress Index - Short Form Total Score
Time frame: Baseline and 2-weeks
Change in the Family Quality of Life Scale Total Score
Time frame: Baseline and 2-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Nowinski, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI) in people with Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score (time frame: Baseline and 2-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.