Autistic Disorder
Conditions
Keywords
Autism PRT
Brief summary
This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. The purpose of this study is to further examine the effectiveness of teaching pivotal response treatment to parents of children with autism in a group format. To determine the effectiveness of pivotal response training group (PRTG) it will be compared to another parent education group by conducting a randomized controlled 12-week trial.
Detailed description
This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of teaching parents how to implement PRT in a group format, as opposed to an individual format. Preliminary data has demonstrated that teaching PRT in a group format has shown to be effective in teaching parents and increasing children's communication skills. The purpose of this study is to further examine the effectiveness of teaching pivotal response treatment to parents of children with autism in a group format. To determine the effectiveness of pivotal response training group (PRTG) it will be compared to another parent education group by conducting a randomized controlled 12-week trial. PRTG will aim to teach parents pivotal response training strategies, whereas the parent psychoeducational group (PEG) will aim to teach parents information with regards to assessment and treatment for children with autism. By conducting this research it will improve researchers understanding of group treatment options for individuals with autism and allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families.
Interventions
BEHAVIORALPivotal Response Training (PRT)
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
BEHAVIORALParent Education Group (PEG)
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Sponsors
Autism Speaks
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview - Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), and expert clinical opinion * Outpatients between 2.0 and 6 years of age of either gender * Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained * Language delay as measured by the Preschool Language Scale 4th ed. (PLS-4) * Participants must have the ability to make meaningful vocalizations, defined as the ability to make contingent vocalizations when prompted (i.e., vocal sound showing intent to communicate, but not necessarily clear words) * Stable psychotropic medication(s) or biomedical interventions for at least one month prior to baseline measurements with no anticipated changes during study participation * Stable behavioral treatment (Applied Behavioral Analysis, Floortime, or other interventions), speech therapy, and school placement for at least 2 months prior to baseline measurements with no expected changes during study participation * No more than 60 minutes of 1:1 speech therapy per week * The availability of at least one parent who can consistently participate in the group treatment and related activities of the research study * Be male or female in good medical health * Will be starting PRTG after the first magnetic resonance image (MRI) scan has occured and, if agreeable, blood draw or saliva sample * Parents intend on continuing PRTG for a minimum of 12 weeks * Parents must be 18 years of age or older.
Exclusion criteria
* A current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder…) * A genetic abnormality, such as Fragile X, based on genetic testing, done as indicated * Presence of active medical problem (e.g., unstable seizure disorder or heart disease) * Participants taking psychotropic medications will not be included if their medications have not been stable for over a week * Parents who do not have the ability to videotape parent and child interactions on a weekly basis * Parents who are not willing to implement intervention strategies for at least one hour a day * Parents who plan to alternate which parent attends the group sessions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks | Baseline, 12 weeks | Total frequency of child's utterances during 10 minute videotaped SLO assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family Empowerment Scale Total Score | Baseline, 12 weeks | Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170). |
| Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score | Baseline, 12 weeks | Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189). |
| Parenting Stress Index Total Score | Baseline, 12 weeks | Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180). |
| Sensory Profile Questionnaire Sensory Seeking Raw Score | Baseline, 12 weeks | Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85). |
| Pediatric Quality of Life Scale Scaled Total Mean Score | Baseline, 12 weeks | Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100). |
| Repetitive Behavior Scale- Revised Total Score | Baseline, 12 weeks | Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129). |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred over 2 years (July 2010-June 2012). Participants were recruited through distribution of fliers at clinics and autism awareness events, referral by local professionals, and word of mouth.
Pre-assignment details
One hundred and thirty-five potential subjects were screened after inquiring about the study; 104 signed a consent form. Forty one did not meet eligibility criteria and 10 decided not to participate before baseline measures.
Participants by arm
| Arm | Count |
|---|---|
| Pivotal Response Training (PRT) Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions. | 27 |
| Parent Education Group (PEG) Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided. | 26 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Changes in concomitant therapies | 2 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Pivotal Response Training (PRT) | Parent Education Group (PEG) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 26 Participants | 53 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
Primary
Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks
Total frequency of child's utterances during 10 minute videotaped SLO assessment.
Time frame: Baseline, 12 weeks
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pivotal Response Training (PRT) | Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks | Baseline Total Utterances of SLO | 45.7 Utterances | Standard Deviation 23.1 |
| Pivotal Response Training (PRT) | Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks | Week 12 Total Utterances of SLO | 64.5 Utterances | Standard Deviation 28.9 |
| Parent Education Group (PEG) | Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks | Baseline Total Utterances of SLO | 40.8 Utterances | Standard Deviation 22.4 |
| Parent Education Group (PEG) | Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks | Week 12 Total Utterances of SLO | 51.4 Utterances | Standard Deviation 33.8 |
Comparison: Group X Time Interaction Cohen's dp-value: 0.42Mixed Effects Regression Model
Secondary
Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score
Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189).
Time frame: Baseline, 12 weeks
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pivotal Response Training (PRT) | Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score | Baseline | 124.19 score on a scale | Standard Deviation 21.17 |
| Pivotal Response Training (PRT) | Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score | Week 12 | 113.28 score on a scale | Standard Deviation 21.44 |
| Parent Education Group (PEG) | Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score | Baseline | 124.19 score on a scale | Standard Deviation 24.69 |
| Parent Education Group (PEG) | Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score | Week 12 | 119.91 score on a scale | Standard Deviation 24.05 |
Secondary
Family Empowerment Scale Total Score
Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).
Time frame: Baseline, 12 weeks
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pivotal Response Training (PRT) | Family Empowerment Scale Total Score | Baseline | 127.78 score on a scale | Standard Deviation 18.18 |
| Pivotal Response Training (PRT) | Family Empowerment Scale Total Score | Week 12 | 130.14 score on a scale | Standard Deviation 18.78 |
| Parent Education Group (PEG) | Family Empowerment Scale Total Score | Baseline | 121.73 score on a scale | Standard Deviation 19.91 |
| Parent Education Group (PEG) | Family Empowerment Scale Total Score | Week 12 | 121.68 score on a scale | Standard Deviation 14.25 |
Secondary
Parenting Stress Index Total Score
Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).
Time frame: Baseline, 12 weeks
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pivotal Response Training (PRT) | Parenting Stress Index Total Score | Baseline | 92.04 score on a scale | Standard Deviation 25.07 |
| Pivotal Response Training (PRT) | Parenting Stress Index Total Score | 12 Weeks | 90.91 score on a scale | Standard Deviation 22.33 |
| Parent Education Group (PEG) | Parenting Stress Index Total Score | Baseline | 98.38 score on a scale | Standard Deviation 26.97 |
| Parent Education Group (PEG) | Parenting Stress Index Total Score | 12 Weeks | 95.95 score on a scale | Standard Deviation 28.53 |
Secondary
Pediatric Quality of Life Scale Scaled Total Mean Score
Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).
Time frame: Baseline, 12 weeks
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pivotal Response Training (PRT) | Pediatric Quality of Life Scale Scaled Total Mean Score | Baseline | 64.86 score on a scale | Standard Deviation 15.72 |
| Pivotal Response Training (PRT) | Pediatric Quality of Life Scale Scaled Total Mean Score | Week 12 | 67.38 score on a scale | Standard Deviation 14.06 |
| Parent Education Group (PEG) | Pediatric Quality of Life Scale Scaled Total Mean Score | Baseline | 67.18 score on a scale | Standard Deviation 15.66 |
| Parent Education Group (PEG) | Pediatric Quality of Life Scale Scaled Total Mean Score | Week 12 | 67.45 score on a scale | Standard Deviation 16.26 |
Secondary
Repetitive Behavior Scale- Revised Total Score
Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129).
Time frame: Baseline, 12 weeks
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pivotal Response Training (PRT) | Repetitive Behavior Scale- Revised Total Score | Baseline | 21.70 score on a scale | Standard Deviation 14.62 |
| Pivotal Response Training (PRT) | Repetitive Behavior Scale- Revised Total Score | Week 12 | 20.04 score on a scale | Standard Deviation 16.69 |
| Parent Education Group (PEG) | Repetitive Behavior Scale- Revised Total Score | Baseline | 26.23 score on a scale | Standard Deviation 22.7 |
| Parent Education Group (PEG) | Repetitive Behavior Scale- Revised Total Score | Week 12 | 30.05 score on a scale | Standard Deviation 24.78 |
Secondary
Sensory Profile Questionnaire Sensory Seeking Raw Score
Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85).
Time frame: Baseline, 12 weeks
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pivotal Response Training (PRT) | Sensory Profile Questionnaire Sensory Seeking Raw Score | Baseline | 60.81 score on a scale | Standard Deviation 9.51 |
| Pivotal Response Training (PRT) | Sensory Profile Questionnaire Sensory Seeking Raw Score | Week 12 | 61.52 score on a scale | Standard Deviation 11.09 |
| Parent Education Group (PEG) | Sensory Profile Questionnaire Sensory Seeking Raw Score | Baseline | 60.92 score on a scale | Standard Deviation 12.02 |
| Parent Education Group (PEG) | Sensory Profile Questionnaire Sensory Seeking Raw Score | Week 12 | 65.52 score on a scale | Standard Deviation 11.86 |