Developmental Behavioral Pediatrics Research Network
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Preliminary Validation of Selected Pediatric PROMIS®

 

Context: Autism spectrum disorder (ASD) is a neurodevelopmental condition that is

estimated to affect as many as 1:88 children. Despite the prevalence of the disorder there

are no widely accepted measures of outcome. Given that ASD has no biological markers of

disease activity, patient or proxy reported outcome measures are needed. Over the past few

years NIH has made a huge investment in the development of patient/proxy reported

outcome measures through the Patient Reported Outcome Measurement Information System

(PROMIS) initiative, but these measures have not been validated for children with ASD.

 

Objectives:

Aim 1 (Quantitative):

Determine the validity of the PROMIS® pediatric parent-proxyreported Peer Relationships, Family Involvement, and Psychological Distress measures in 5-12 year old children with ASD.

Aim 2 (Qualitative):

Elucidate how appropriately parents believe the PROMIS measures assess the constructs of peer relationships, family involvement, and psychological distress in their 5-12 year old children with ASD.

Study Design:

This is a cross sectional mixed methods study to perform a preliminary study of the validity of selected PROMIS measures in children with ASD.

Setting/Participants:

 

Parents of 5-12 year old children with a diagnosis of ASD will be enrolled at 3 sites that participate in the Developmental-Behavioral Pediatrics Research Network (DBPNet). We will enroll approximately 80 subjects at each site (240 subjects study-wide) in the quantitative component of this study and approximately 20 subjects at each site (60 subjects study-wide) in the semi-structured interviews.

Study Interventions and Measures:

Study procedures include a review of the child’s medical record and the parent/caregiver completes the parent proxy versions of the PROMIS® Peer Relationships, Psychological Distress, and Family Involvement measures along with established measures of autism severity, parental depression, and parenting stress. In addition, a subset of primary caregivers participate in one-time individual semi-structured interviews to explore how comprehensively and appropriately the PROMIS measures assess the characteristics of peer relationships, psychological distress, and family involvement in relation to the experiences of their child with ASD.