Telehealth Rapid Intervention for Externalizing Behaviors in ASD
- Conditions
- Disruptive BehaviorAutism Spectrum DisorderTelehealthExternalizing BehaviorParent-Child Interaction Therapy
- Interventions
- Behavioral: Tele-PCITBehavioral: Treatment as Usual
- Registration Number
- NCT05056922
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
The purpose of this research study is to evaluate a time-limited version of Parent Child Interaction Therapy (PCIT) delivered via telehealth for young children with autism spectrum disorder (ASD) and disruptive behavior problems. Families will be randomly assigned to receive 10 sessions of Tele-PCIT or Treatment as Usual. Families will complete a baseline assessment, a post-treatment assessment, and a 3-month follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 80
- Be between 2:0 -6:11 years old
- Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory
- Have a diagnosis of ASD based on a positive Autism Diagnostic Observation Schedule (ADOS-2), a semi-structured parent interview, record review, and an ASD DSM-5 criteria checklist.
- Have a receptive language age equivalent of at least 24 months as defined by the Peabody Picture Vocabulary Test
- Are of low SES background defined by having primary Medicaid
- Presence of severe self-injurious behavior
- Children who are receiving psychotropic medication and are not stable on their current medication regimen. Children receiving psychotropic medications who are on a stable regimen for one month will not be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tele-PCIT (Parent-Child Interaction Therapy) Tele-PCIT - Treatment as Usual Treatment as Usual -
- Primary Outcome Measures
Name Time Method Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R) Pre-treatment to follow-up (~24 weeks) The SESBI is a 38-item measure of disruptive behavior utilized across the PCIT literature. Teachers will rate the current frequency of child behavior problems on a 7-point Likert scale and determine whether or not they find the behaviors to be problematic. The SESBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity.
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF) Pre-treatment to follow-up (~24 weeks) Parents will complete the PSI-SF, a 36-item measure yielding scores for a Total Stress scale. The PSI-SF is a widely used measure in ASD samples and has been used as an outcome measure in PCIT ASD studies. The PSI-SF yields a total raw score for stress level and a percentile score which describes parent stress relative to all parents assessed during the development and testing of the PSI. Scores above 80 are considered high stress scores.
Change in Parenting Practices as assessed by Parenting Scale (PS) Pre-treatment to follow-up (~24 weeks) Parents will complete the PS, which has been consistently used across the PCIT literature as a measure of parenting practices. The PS is a 30-item measure, which yields a Total score representing an average of responses on all items, and individual scale scores for Laxness, Over-reactivity, and Negativity. A higher score on the scale scores and on the Total score indicates a greater level of reported problematic parenting discipline style.
Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI) Pre-treatment to follow-up (~24 weeks) The ECBI is a 36-item measure of disruptive behavior problems utilized across the PCIT literature. Parents will rate the frequency of child behaviors on a 7-point Likert scale. The ECBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity. The cut-off for clinical significance is a raw score of 130.
Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV) Pre-treatment to follow-up (~24 weeks) The DPICS-IV observational paradigm and coding system is the gold standard for assessing parent and child observational outcomes across the PCIT literature. During each 5-minute parent-child situation (child-led, parent-led, clean-up), parents are provided standardized instructions via a bug-in-the-ear across a one-way mirror or video. All families are provided with the same set of standard toys during the observation. Each observation will be video recorded and subsequently coded for child compliance to commands and parenting "do" and "don't" skills by student research assistants who will be trained to research reliability and blinded to the child intervention status and timepoint.
Change in Child Behavior Problems as assessed by Behavior Assessment System for Children-3rd Edition (BASC-3) Pre-treatment to follow-up (~24 weeks) Parents and teachers will complete the BASC-3, a broadband assessment that includes disruptive behavior domains including hyperactivity, aggression, and attention problems, in addition to a general externalizing behavior problems composite. The BASC-3 has excellent reliability and validity and has been utilized extensively across the ASD literature and in examinations of PCIT with ASD samples. The Preschool versions will be used for children 2 to 5 years old, and the Child version will be used for children 6:0+.
Change in Child Behavior Problems as assessed by Disruptive Behavior Disorders Rating Scale (DBD) Pre-treatment to follow-up (~24 weeks) The DBD is a 45-item measure of disruptive behavior and symptoms of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) that has been utilized in samples of preschoolers with ADHD and ODD, and in studies examining ADHD symptoms in samples of children with ASD. Parents and teachers will complete the DBD, rating each item on a four-point scale ranging from not at all (0) to very much (3).
- Secondary Outcome Measures
Name Time Method Impact of Barriers on Treatment Engagement as assessed by Barriers to Treatment Participation Scale (BTPS) Pre-treatment to post-treatment (~12 weeks) Parents in Tele-PCIT will complete the BTPS at post-treatment to assess for the impact of barriers on treatment engagement throughout the intervention. The BTPS is a 44 item rating of how much parents agree with statements about their expectancies of barriers to treatment participation for their child, using a 5-point Likert scale (1=totally disagree, 5= totally agree). This measure has been used in other PCIT studies comparing engagement between clinic and telehealth delivery.
Parent Satisfaction with Tele-PCIT as assessed by Therapy Attitude Inventory (TAI) Pre-treatment to post-treatment (~12 weeks) To assess treatment satisfaction, parents will complete the TAI, which is widely used in PCIT studies. Several questions will be added to the TAI to address parental satisfaction and openness regarding the telehealth delivery format for families in the Tele-PCIT condition. The TAI uses a Likert-type satisfaction scale and scores will be reported via descriptive statistics with 95% CIs within categories.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States