Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention
ConditionAutism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-36
SponsorUniversity of South Carolina
About this trial
Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Able to provide written and informed consent;
Both sexes and all racial and ethnic origins;
English fluency (necessary for informed consent and measure completion)
Is between 18 and 75 years of age
Trial design
Design model
Parallel
Treatments tested in this trial
Parent Training
BehavioralParticipants will receive a form of behavioral parent training as described in the "Manage Your Child's Challenging Behavior" module of Project ImPACT.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Parent TrainingExperimental treatment 1 intervention
Group B: EI Practice-As-Usual (PAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Parent Training Treatment Acceptability
Participants receiving Parent Training will complete an 18-item measure of treatment acceptability adapted from the Scale of Treatment Perceptions (STP; Berger et al., 2016). Treatment acceptability comprises how effective a participant views an intervention to be, as well as how feasible, acceptable, and appropriate it is. A composite average score will be calculated, and additional availability domains include "effectiveness", "family fit," and "negative aspects" of the intervention. Participants will rate each item on a Likert scale (1 = Strongly Disagree; 7 = Strongly Agree). A higher score (maximum = 7; minimum = 1) indicates greater treatment acceptability.
Time frame
8 weeks after the start of intervention (1-3 weeks post intervention)Secondary outcomes
1
Parent Training Fidelity
Providers and caregivers will complete a Knowledge Quiz after each PT session, which will be videotaped and coded for fidelity. Dr. Ingersoll will mentor Dr. Edmunds to create a fidelity assessment for Parent Training using the CORE Fidelity Method. The RISE Modification \& Adaptation survey, based on FRAME will be used to code incidental modifications
Time frame
Weekly up to 8 weeks2
Parent Training Family Fit
Caregivers in the PT group will complete the FVAI, an interview about their family values and daily activities, and how PT fits or could fit within these.
Time frame
8 weeks after the start of intervention (1-3 weeks post intervention)3
Parent Training Readiness
Readiness to implement an EBP is multidimensional and is conceptualized to consist of all of the internal preconditions to EBP use in the Theory of Planned Behavior: EBP 1) attitudes; 2) norms; and 3) self-efficacy. We will use a customized version of the EBP Attitudes Scale, a 15-item scale with the best psychometrics compared to similar measures. We will assess providers' and caregivers' readiness to try using each PT strategy separately.
Time frame
Weekly up to 8 weeks4
Child Emotion Regulation
The preliminary effectiveness of Parent Training vs. PAU on child emotion regulation will be assessed using a composite of the MAP-DB Temper Loss scale, the EDI-YC Reactivity Index, the HSQ-ASD, and the DB-DOS. The first 3 are Likert scale parent-report questionnaires (22 items, 15 items, and 16 items, respectively) with good psychometric properties. The MAP-DB measures the intensity, frequency, and context of irritable behavior and is valid in autism. The EDI-YC is a well validated measure of emotion dysregulation in autism. The HSQ-ASD is a behaviorally specific questionnaire that is sensitive to change and will be used to track interim weekly progress. The DB-DOS8 is a standardized, clinician-administered observational measure of irritability with prior use in autism.
Time frame
8 weeks after the start of intervention (1-3 weeks post intervention)Sponsors and contacts
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University of South Carolina
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov