Autism Spectrum Disorder
Conditions
Keywords
Parent Training, Aggressive Behavior
Brief 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).
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.
Interventions
BEHAVIORALParent-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.
Sponsors
Crisis Prevention Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
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): * 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. * 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Parent Stress Index - Short Form Total Score | Baseline and 2-weeks | 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. |
| Change in the Family Quality of Life Scale Total Score | Baseline and 2-weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
One participant withdrew consent prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 28 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not return study questionnaires | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 5 |
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | CPI-Parent Training | Waitlist Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 28 Participants | 63 Participants |
| Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score | 111.3 units on a scale STANDARD_DEVIATION 21.8 | 101.3 units on a scale STANDARD_DEVIATION 17.8 | 106.8 units on a scale STANDARD_DEVIATION 20.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 26 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Family Quality of Life Scale Total Score | 93.3 units on a scale STANDARD_DEVIATION 11.8 | 90.5 units on a scale STANDARD_DEVIATION 13.9 | 92.1 units on a scale STANDARD_DEVIATION 12.7 |
| Parent Stress Index - Short Form Total Score | 115.0 units on a scale STANDARD_DEVIATION 19.4 | 117.6 units on a scale STANDARD_DEVIATION 21 | 116.2 units on a scale STANDARD_DEVIATION 20 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 27 Participants | 58 Participants |
| Region of Enrollment United States | 35 participants | 28 participants | 63 participants |
| Sex: Female, Male Female | 32 Participants | 25 Participants | 57 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 28 |
| other Total, other adverse events | 0 / 35 | 0 / 28 |
| serious Total, serious adverse events | 0 / 35 | 0 / 28 |
Outcome results
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.
Time frame: Baseline and 2-weeks
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CPI-Parent Training | Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score | 8.3 units on a scale |
| Waitlist Control | Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score | 2.5 units on a scale |
p-value: 0.1195% CI: [-1.4, 13.1]Regression, Linear
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.
Time frame: Baseline and 2-weeks
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CPI-Parent Training | Change in the Family Quality of Life Scale Total Score | 1.9 units on a scale |
| Waitlist Control | Change in the Family Quality of Life Scale Total Score | 1.3 units on a scale |
p-value: 0.7295% CI: [-2.9, 4.2]Regression, Linear
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.
Time frame: Baseline and 2-weeks
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CPI-Parent Training | Change in the Parent Stress Index - Short Form Total Score | -2.7 units on a scale |
| Waitlist Control | Change in the Parent Stress Index - Short Form Total Score | -0.5 units on a scale |
p-value: 0.495% CI: [-7.4, 3]Regression, Linear