PRTG: Pivotal Response Group Treatment for Parents of Young Children With Autism

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01881750
• Collaborator: Autism Speaks (Other)
• Enrollment: 53
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder	Behavioral: Pivotal Response Training (PRT); Behavioral: Parent Education Group (PEG)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Response Group Treatment for Parents of Young Children With Autism
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pivotal Response Training (PRT) 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Behavioral: Pivotal Response Training (PRT); 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Placebo Comparator: Parent Education Group (PEG) 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.	Behavioral: Parent Education Group (PEG); 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

6. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University
• Autism Speaks

Investigators

• Principal Investigator: Antonio Hardan, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonio Hardan, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT01881750
• Other Study ID Numbers: SU-11022010-7151
• First Posted: Jun 20, 2013
• Last Update Posted: Aug 16, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Antonio Hardan, Professor, Stanford University: Autism PRT
• Additional relevant MeSH terms: Autistic Disorder

Study Results

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 Detail	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.

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Period Title: Overall Study
STARTED	27	26
COMPLETED	25	22
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)	Total
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.	Total of all reporting groups
Overall Participants	27	26	53
Age (Count of Participants)
<=18 years	27 100%	26 100%	53 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	6 22.2%	6 23.1%	12 22.6%
Male	21 77.8%	20 76.9%	41 77.4%
Region of Enrollment (Count of Participants)
United States	27 100%	26 100%	53 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks
Description	Total frequency of child's utterances during 10 minute videotaped SLO assessment.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)
Arm/Group Description	12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions. Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	12 week program consisting of offering/discussion information for parents. No pivotal response training provided. Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Measure Participants	25	22
Baseline Total Utterances of SLO	45.7 (23.1)	40.8 (22.4)
Week 12 Total Utterances of SLO	64.5 (28.9)	51.4 (33.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pivotal Response Training (PRT), Parent Education Group (PEG)
	Comments	Group X Time Interaction Cohen's d
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	Mixed Effects Regression Model
	Comments

2. Secondary Outcome

Title	Parenting Stress Index Total Score
Description	Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Measure Participants	27	26
Baseline	92.04 (25.07)	98.38 (26.97)
12 Weeks	90.91 (22.33)	95.95 (28.53)

3. Secondary Outcome

Title	Family Empowerment Scale Total Score
Description	Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Measure Participants	27	26
Baseline	127.78 (18.18)	121.73 (19.91)
Week 12	130.14 (18.78)	121.68 (14.25)

4. Secondary Outcome

Title	Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score
Description	Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189).
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Measure Participants	27	26
Baseline	124.19 (21.17)	124.19 (24.69)
Week 12	113.28 (21.44)	119.91 (24.05)

5. Secondary Outcome

Title	Repetitive Behavior Scale- Revised Total Score
Description	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

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Measure Participants	27	26
Baseline	21.70 (14.62)	26.23 (22.70)
Week 12	20.04 (16.69)	30.05 (24.78)

6. Secondary Outcome

Title	Sensory Profile Questionnaire Sensory Seeking Raw Score
Description	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

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Measure Participants	27	25
Baseline	60.81 (9.51)	60.92 (12.02)
Week 12	61.52 (11.09)	65.52 (11.86)

7. Secondary Outcome

Title	Pediatric Quality of Life Scale Scaled Total Mean Score
Description	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

Outcome Measure Data

Analysis Population Description

Participants with available data.

Arm/Group Title	Pivotal Response Training (PRT)	Parent Education Group (PEG)
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.	Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Measure Participants	27	26
Baseline	64.86 (15.72)	67.18 (15.66)
Week 12	67.38 (14.06)	67.45 (16.26)

Adverse Events

Arm/Group Title	Pivotal Response Training (PRT)		Parent Education Group (PEG)
Arm/Group Description	Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.		Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
All Cause Mortality
	Pivotal Response Training (PRT)		Parent Education Group (PEG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pivotal Response Training (PRT)		Parent Education Group (PEG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Pivotal Response Training (PRT)		Parent Education Group (PEG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)

Limitations/Caveats

The moderate sample size meant that power to detect complex multicomponent patterns was limited. There is also no information available about longer term effects of the treatment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.