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Trends in ASD Pharmacological Research: An Analysis of

Cervantes, Paige E.; Conlon, Greta R.; Shalev, Rebecca A.; Castellanos, F. Xavier
Despite decades of research, both understanding and availability of pharmacological interventions for autistic people are limited. We examined characteristics of pharmacological trials on (N = 235) to elucidate trends, identify gaps, and suggest future research directions. We observed that trials predominantly sampled school-aged children and adolescents and focused largely on core autism symptoms, neglecting younger children and adults as well as associated symptom domains often identified by stakeholders as treatment priorities. A variety of intervention agents were trialed, with nearly 60% appearing in just one study. Notably, in line with previous research, there was little consistency in outcome measures used, with the majority (58.9%) used in only one trial. Innovation in research strategies is urgently needed; potential directions for such changes are discussed.
ISSN: 2195-7177
CID: 5145062

6.32 Assessing the Effect of Youth Involvement in Adverse Event Reporting during a Clinical Trial of Cannabidiol for Youth WITH AUTISM SPECTRUM DISORDER with Complex Verbal Language [Meeting Abstract]

Lawson, J; Conlon, G; Cervantes, P; Shalev, R; Castellanos, F X
Objectives: Clinical trials in youth with autism spectrum disorder (ASD) have typically neglected the voices of the youth themselves. Besides raising ethical questions, this may also affect the quality of the data obtained. We examined differences in adverse event (AE) reporting between parents and parent-child dyads in an open trial of cannabidiol (CBD). We hypothesized that including youth with ASD in AE reporting would increase the number of total and related AEs independently of response.
Method(s): Twelve youth (ages 7-14 years) with ASD (verbally fluent, IQ >= 80) completed a 6-week, Phase 2 open trial of 98% CBD (Epidiolex [V], 100 mg/mL) at 3 or 6 mg/kg/day; target N = 30. An individualized target symptom domain was identified at baseline by clinician consensus from informant report, rating scales, and clinical observation. Responders were defined by Clinical Global Impression Scale-Improvement (CGI-I) <= 2 in their target symptom domain. AEs were assessed by phone with parents (weeks 1, 3, 5) and via the UKU (Udvalg for Kliniske Under-sogelser) Side Effects Rating Scale administered by clinicians to dyads (weeks 2, 4, 6). Clinician consensus determined the relatedness of AEs to treatment. Disease-related events (DREs) were considered adverse if the severity or frequency increased. In this interim analysis, we identified response to treatment and AEs, contrasted AE rates (parents vs dyads), and examined the relationship between treatment response and AE profile.
Result(s): All 12 initial participants completed the trial; 4 responded (33%). Clinical Global Impression Scale-Severity (CGI-S) improved significantly from pre- (M = 4.83; SD = 0.39) to posttreatment (M = 3.92; SD = 0.90) (t11 = 3.53; p < 0.004). The most frequent AEs were tiredness (n = 5) and increased emotionality (n = 3). Of 47 total AEs, all were mild and 39 were first reported by dyads. Of 14 related AEs, 9 were first reported by dyads. One DRE occurred: increased severity of restricted, repetitive behaviors. The number of AEs reported by dyads (M = 3.25; SD = 3.14) compared to parents alone (M = 0.67; SD = 0.89) was significantly higher (t11 = 2.18; p = 0.017). Responders and nonresponders did not differ significantly in the number of total or related AEs.
Conclusion(s): This interim analysis suggests that including the input of children with ASD in AE reporting captures a fuller profile of total and related AEs without compromising the study integrity or results. ASD, OLT, R
ISSN: 1527-5418
CID: 5024292

A systematic review of the role of parent characteristics in parent-mediated interventions for children with autism spectrum disorder

Shalev, Rebecca A; Lavine, Caila; Di Martino, Adriana
Parent-mediated interventions (PMI) are increasingly being used to target skill deficits in children with Autism Spectrum Disorder (ASD). Evidence documenting the benefits of PMI is accumulating, however, little is known about whether parent characteristics impact children's treatment outcomes. We reviewed the PMI literature using PRISMA guidelines to address this gap. We identified 115 PMI studies published between 1987 and September 2018; of these, only 11 examined the contributions of baseline parent/caregiver characteristics on children's outcomes. These studies vary widely in regard to the interventions employed and outcome measures explored. Early intervention programs were the most common form of treatment and stress was the most frequently targeted parent/caregiver characteristic. Results indicated that stress, socioeconomic status, and the broad autism phenotype may be related to children's outcomes, with varying effects depending on the specific treatment and outcome examined. These results underscore the need for systematic research on the role of parent baseline characteristics in PMI. A deeper understanding of the relationship between parent/caregiver variables and child outcomes may inform treatment selection and elucidate key mechanisms of therapeutic change. (PsycInfo Database Record (c) 2021 APA, all rights reserved)
ISSN: 1573-3580
CID: 4901052

Definition and diagnosis

Chapter by: Cervantes, Paige; Shalev, Rebecca; Donnelly, Lauren
in: Handbook of intellectual disabilities: Integrating theory, research, and practice by Matson, Johnny L [Ed]
Cham, Switzerland: Springer Nature Switzerland AG; Switzerland, 2019
pp. 45-59
ISBN: 978-3-030-20842-4
CID: 5096642

Treating liquid expulsion in children with feeding disorders

Shalev, Rebecca A; Milnes, Suzanne M; Piazza, Cathleen C; Kozisek, Jennifer M
In the current investigation, we compared and evaluated the effects of two intervention procedures, a modified chin prompt and reclined seating, on the liquid expulsion of 2 children with feeding disorders. For both participants, expulsion decreased to clinically meaningful levels when we added the modified chin prompt or reclined seating to a treatment package consisting of differential reinforcement of acceptance, nonremoval of the cup, and re-presentation. We discuss possible mechanisms underlying the effects of the 2 interventions and areas for future research.
PMID: 29315548
ISSN: 1938-3703
CID: 2916622

The relationship between parent and child characteristics among families receiving a caregiver-mediated social skills intervention for autism [Meeting Abstract]

Shalev, R A; Gordillo, M; Sullivan, K; Chen, B; Doggett, R; Laugeson, E; Kuriakose, S; DiMartino, A
Objectives: A growing literature indicates that caregiver-mediated social skills interventions increase social competence among children with autism; however, very little is known about the role of parent characteristics in treatment success. As an initial step toward closing this gap, we examined the following: 1) the feasibility of collecting measures of caregivers and children enrolled in these interventions in a clinic setting; and 2) the relationships between baseline measures of caregivers and their children. Methods: We enrolled 19 children with autism (15 males; mean age = 11 +/- 3 years) and 19 caregivers (one per child; 15 females; mean age = 48 +/- 8 years) in either the Program for the Education and Enrichment of Relational Skills (PEERS) or the Children's Friendship Training. The Social Responsiveness Scale, 2nd Edition parent report (SRS-2-P) and the Child Behavior Checklist (CBCL) parent report were used to index children's autism severity and their internalizing and externalizing symptoms of psychopathology. Parent autistic traits were assessed using the SRS-2 adult form (SRS-2-A), which were completed by their spouses. Parent-rated Positive Affect Index (PAI) assessed the quality of the parent-child relationship. We measured the relationship between child and caregiver characteristics using two-tailed bivariate correlations. Results: Relationship quality, as measured by the PAI, varied across families (mean age = 47 +/- 8 years). High relationship quality was correlated negatively with scores of the CBCL Externalizing Problems Scale (r = -0.69, P = 0.004) and several subscales that load onto this scale (e.g., aggressive behavior, r = -0.73, P = 0.002). The SRS-2-P scores indicated that children have clinically significant scores, whereas the SRS-2-A scores indicate their caregivers do not. There was no significant relationship between SRS-2-P and SRS-2-A scores (r = -0.03, P = 0.94) or PAI and SRS-2-P scores (r = -0.30, P = 0.40). Conclusions: Results indicate that it is feasible to collect caregiver and child data in the context of a clinic-based, caregiver-mediated intervention. Preliminary data underscore the relationship between caregiver-child relationship quality and externalizing behavioral challenges in children with autism. This relationship should be investigated as a potential mediator of treatment effects
ISSN: 1527-5418
CID: 2401572

Randomized Evaluation of Peer Support Arrangements to Support the Inclusion of High School Students With Severe Disabilities

Carter, Erik W; Asmus, Jennifer; Moss, Colleen K; Biggs, Elizabeth E; Bolt, Dan M; Born, Tiffany L; Brock, Matthew E; Cattey, Gillian N; Chen, Rui; Cooney, Molly; Fesperman, Ethan; Hochman, Julia M; Huber, Heartley B; Lequia, Jenna L; Lyons, Gregory; Moyseenko, Kerrie A; Riesch, Lindsay M; Shalev, Rebecca A; Vincent, Lori B; Weir, Katie
Enhancing the social and learning experiences of students with severe disabilities in inclusive classrooms has been a long-standing focus of research, legislative, and advocacy efforts. The authors used a randomized controlled experimental design to examine the efficacy of peer support arrangements to improve academic and social outcomes for 51 students with severe disabilities in high school general education classrooms. Paraprofessionals or special educators recruited, trained, and supported 106 peers to provide individualized academic and social assistance to students with severe disabilities throughout one semester. Compared to students exclusively receiving adult-delivered support (n = 48), students participating in peer support arrangements experienced increased interactions with peers, increased academic engagement, more progress on individualized social goals, increased social participation, and a greater number of new friendships. Moreover, an appreciable proportion of relationships lasted one and two semesters later after the intervention had concluded. These findings challenge prevailing practices for supporting inclusive education and establish the efficacy and social validity of peer support arrangements as a promising alternative to individually assigned paraprofessional support.
ISSN: 2163-5560
CID: 2180622

Early Diagnostic Assessment

Chapter by: Kuriakose, Sarah; Shalev, Rebecca
in: Early intervention for young children with autism spectrum disorder by Lang, Russell; Hancock, Terry B; Singh, Nirbhay N [Eds]
[S.l.] : Springer, 2016
pp. 15-46
ISBN: 3319309234
CID: 2180652

Attitudes of High School Students toward their Classmates with Severe Disabilities: a Pilot Study

Shalev, Rebecca A; Asmus, Jennifer M; Carter, Erik W; Moss, Colleen K
Calls to expand inclusive education for students with severe disabilities are pervasive throughout recent policy and research initiatives. The perspectives of peers without disabilities on such inclusion are an important vantage point to understand, particularly at the high school level. In this pilot study, we examined the attitudes of 44 high school peers who were enrolled in general education classes with students with severe disabilities. Overall, these peers reported fairly high levels of exposure and contact with students with severe disabilities. Moreover, they largely endorsed positive attitudes towards adolescents with severe disabilities and inclusion. However, significant gender differences were found, with females demonstrating more positive attitudes than males. We discuss implications for research and practice focused on enhancing positive attitudes toward and relationships among students with and without severe disabilities at the high school level.
ISSN: 1573-3580
CID: 2347612

A Behavior-Analytic Approach to the Assessment and Treatment of Pediatric Feeding Disorders

Chapter by: Piazza, Cathleen; Milnes, Suzanne M; Shalev, Rebecca
in: Clinical and organizational applications of applied behavior analysis by Roane, Henry S; Ringdahl, Joel L; Falcomata, Terry S [Eds]
London, UK ; San Diego : Academic Press, 2015
pp. 69-94
ISBN: 0124202497
CID: 2180642