A Pilot Feasibility Study Assessing the Combined Effects of Early Behavioral Intervention and Propranolol on Autism Spectrum Disorder (ASD)

Abstract

Autism spectrum disorder (ASD), a neurodevelopmental disorder typified by differences in social communication as well as restricted and repetitive behaviors, is often responsive to early behavioral intervention. However, there is limited information on whether such intervention can be augmented with pharmacological approaches. We conducted a double-blinded, placebo-controlled feasibility trial to examine the effects of the β-adrenergic antagonist propranolol combined with early intensive behavioral intervention (EIBI) for children with ASD. Nine participants with ASD, ages three to ten, undergoing EIBI were enrolled and randomized to a 12-week course of propranolol or placebo. Blinded assessments were conducted at baseline, 6 weeks, and 12 weeks. The primary outcome measures focusing on social interaction were the General Social Outcome Measure-2 (GSOM-2) and Social Responsiveness Scale-Second Edition (SRS-2). Five participants completed the 12-week visit. The sample size was insufficient to evaluate the treatment efficacy. However, side effects were infrequent, and participants were largely able to fully participate in the procedures. Conducting a larger clinical trial to investigate propranolol’s effects on core ASD features within the context of behavioral therapy will be beneficial, as this will advance and individualize combined therapeutic approaches to ASD intervention. This initial study helps to understand feasibility constraints on performing such a study.

Keywords: autism; clinical trial; early intervention; propranolol.

Everyone who has looked for support for autism spectrum disorder is familiar with waitlists. Waitlists for evaluation, diagnosis, intervention, consultations and referrals. These waitlists prevent important opportunities for services and many groups developing technologies, policies, and approaches to reduce the waitlists or work around them. On this week’s podcast, we talk to Dr. Sharief Taraman from Cognoa to hear about their recent study on the scope of the problem on waitlists, what causes them, and how digital therapeutics may help them.

In recognition of September 26th, this week’s podcast episode explores one of the more dangerous issues in autism: wandering. But it’s really not wandering in the traditional sense. Wandering in autism mostly means running off, bolting, deliberately with intent and without permission. Obviously this leads to some very dangerous situations for people on the spectrum. How can it be mitigated or understood? Some behavioral therapies are helpful, but new technologies have allowed for more options to bring back loved ones that have run off unexpectedly. Finally, the community needs to be better aware of possible stressors or triggers that trigger a wandering episode and work together with families to prevent running off. This problem is not caused by one thing, and the community needs multiple solutions to keep kids and adults safe.

www.september26.org

https://pubmed.ncbi.nlm.nih.gov/37492814/

https://pubmed.ncbi.nlm.nih.gov/32576789/

Background: Fidelity, or the degree to which an intervention is implemented as designed, is essential for effective implementation. There has been a growing emphasis on assessing fidelity of evidence-based practices for autistic children in schools. Fidelity measurement should be multidimensional and focus on core intervention components and assess their link with program outcomes. This study evaluated the relation between intervention fidelity ratings from multiple sources, tested the relation between fidelity ratings and child outcomes, and determined the relations between core intervention components and child outcomes in a study of an evidence-based psychosocial intervention designed to promote inclusion of autistic children at school, Remaking Recess.

Method: This study extends from a larger randomized controlled trial examining the effect of implementation support on Remaking Recess fidelity and child outcomes. Schools were randomized to receive the intervention or the intervention plus implementation support. Observers, intervention coaches, and school personnel completed fidelity measures to rate completion and quality of intervention delivery. A measure of peer engagement served as the child outcome. Pearson correlation coefficients were calculated to determine concordance between raters. Two sets of hierarchical linear models were conducted using fidelity indices as predictors of peer engagement.

Results: Coach- and self-rated completion and quality scores, observer- and self-rated quality scores, and observer- and coach-rated quality fidelity scores were significantly correlated. Higher observer-rated completion and quality fidelity scores were predictors of higher peer engagement scores. No single intervention component emerged as a significant predictor of peer engagement.

Conclusions: This study demonstrates the importance of using a multidimensional approach for measuring fidelity, testing the link between fidelity and child outcomes, and examining how core intervention components may be associated with child outcomes. Future research should clarify how to improve multi-informant reports to provide “good enough” ratings of fidelity that provide meaningful information about outcomes in community settings.

Plain language summary: Fidelity is defined as how closely an intervention is administered in the way the creators intended. Fidelity is important because it allows researchers to determine what exactly is leading to changes. In recent years, there has been an interest in examining fidelity of interventions for autistic children who receive services in school. This study looked at the relationship between fidelity ratings from multiple individuals, the relationship between fidelity and child outcomes, and the relationship between individual intervention component and child changes in a study of Remaking Recess, an intervention for autistic children at school. Schools were randomly selected to receive the intervention only or the intervention plus implementation support from the research team. Observers, intervention coaches, and individuals delivering the intervention themselves completed fidelity measures. Child engagement with peers was measured before and after the intervention. Several measures of self-, coach-, and observer-report fidelity were associated with each other. Higher observer-reported fidelity was associated with higher child peer engagement scores. No single intervention step was linked to child peer engagement and both treatment groups had similar outcomes in terms of fidelity. This study shows the importance of having multiple raters assess different parts of intervention fidelity, looking at the link between fidelity and child outcomes, and seeing how individual intervention steps may be related to outcomes. Future research should aim to find out which types of fidelity ratings are “good enough” to lead to positive changes following treatment so that those aspects can be used and targeted in the future.

Keywords: autism spectrum disorder; fidelity; implementation; school-based; social engagement intervention.

Everyone needed support during the pandemic, but families affected by autism needed special support. This included siblings. Researchers at Massachusetts General Hospital tried out an intervention around stress and anxiety reduction in siblings in 2020. Not only was it liked, it worked. It didn’t completely eliminate stress and anxiety, nothing would, but it did help siblings manage a little better. Can it work outside the pandemic? There are certainly other situations where siblings could use a little more support – listen to this week’s podcast to learn more.

https://pubmed.ncbi.nlm.nih.gov/36460184/

https://link.springer.com/article/10.1007/s10803-022-05500-7

https://onlinelibrary.wiley.com/doi/10.1002/aur.2987

https://onlinelibrary.wiley.com/doi/10.1002/aur.2987#aur2987-bib-0032

The disparity in diagnosis between Black kids and white kids is narrowing, but not by luck or coincidence. Based on previous research, clinicians are altering their professional training and their outreach to make sure more Black families are diagnosed and receive interventions. On today’s podcast, we highlight a recent study that focused on different ways to lower the age of diagnosis and improve access to early intervention in Black families. This intervention improved cognitive outcomes in Black kids.

https://pubmed.ncbi.nlm.nih.gov/36443922/

https://pubmed.ncbi.nlm.nih.gov/37196781/

Last week in Stockholm, Sweden, 2200 researchers and scientists working to understand and help those on the spectrum, met to share their most recent findings and exchange ideas. What were the main takeaways as ASF saw them? In our latest podcast episode, we cover why some autistic people don’t want genetics to be studied, how to better engage families with IDD and who are non-speaking, females, adults, international studies and yes, diversity. The program book was released a day before the meeting and can be found here: https://cdn.ymaws.com/www.autism-insar.org/resource/resmgr/docs/annualmeeting/insar2023_program_book.pdf

In this week’s podcast, we talk to Whitney Guthrie from Children’s Hospital of Philadelphia who spent the last 6 years conducting the gold-standard randomized control trial that demonstrates intervention for social communication skills at 18 months shows greater effects than intervention starting at 27 months. If you wanted evidence that earlier is better, here it is! Interventions and supports are important at any age, but the critical window of development between 18-27 months is particularly important for long term development.

https://pubmed.ncbi.nlm.nih.gov/36922406/

What do anxiety, prevalence, ketamine, other neurodevelopmental disorders, siblings, genetics, brain imaging and the autistic researcher committee at INSAR all have in common? They were all topics at the last Day of Learning. You can hear a 20 minute summary of the talks on this week’s ASFpodcast.

Parent-focused interventions have been designed to provide training and support to caregivers who are essential in achieving positive outcomes for children with intellectual and developmental disabilities (IDD). In 2020, significant crises, including the COVID-19 pandemic and continued racial tensions, profoundly impacted the livelihood of children with IDD and their families. Many ongoing efforts to address disparities among this population were halted temporarily and required further adaptations. Researchers adapted interventions and support to address the disparities impacting children with IDD and their families with limited guidance. We provide a descriptive case analysis of four parent-focused interventions that responded to the global crises to continue serving children with IDD and their families. The four distinct programs were based on applied behavior analysis and naturalistic, developmental-behavioral paradigms that were culturally adapted for families of young children with IDD from diverse cultural and socioeconomic backgrounds. We present the qualitative reports on the challenges and benefits that arose with adapting the four parent-focused interventions for telehealth implementation. We focused specifically on adaptations made in recruitment and retention, instrumentation and measurement, research staff training, and intervention delivery. We synthesize our experience with challenges and solutions in adapting parent-focused interventions for racially/ethnically and socioeconomically diverse children with IDD and their families. We conclude with recommendations for researchers and practitioners on methods for adapting parent-focused interventions to address the significant health disparities that impact racially, ethnically, and socioeconomically diverse children with IDD and their families.

Keywords: COVID-19; autism; intellectual disability; parent-focused interventions; practice; racial/ethnic diversity.