Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study

Abstract

Parents of children participating in this trial were highly satisfied and supportive of the clinical trial procedures. Random assignment to drug or placebo and the clinical response of their children did not appear to influence their views. Further satisfaction studies of this sort are encouraged.

Caregiver Satisfaction with a Multisite Trial of Atomoxetine and Parent Training for Attention-Deficit/Hyperactivity Disorder and Behavioral Noncompliance in Children with Autism Spectrum Disorder

“…Notably, these are elements of the research experience that may set research apart from routine treatment (e.g., few families would willingly choose a distant care provider, whereas the distance from home to the research laboratory was an unfortunate fact of life that could not be optimized for every participant). In general, the high level of satisfaction in the current study confirms findings in earlier studies (Aman and Wolford 1995;McAdam et al 2002;Tierney et al 2007;Rundberg-Rivera et al 2015). We found, much as previous studies did, that caregiver satisfaction was not necessarily linked to perceived clinical response, as both responders and nonresponders to the study interventions were satisfied with the study as a whole.…”

“…Our study corroborates a previous finding (Tierney et al 2007) that lower income families were less satisfied with the number of visits necessary to complete the study. A possibly related finding is that younger fathers also tended to be less satisfied with the length of PT sessions.…”

“…In studies of children with autism spectrum disorder (ASD), patient and caregiver satisfaction is routinely assessed for one-to-one behavioral interventions (Storey and Horner 1991;Bitterman et al 2008;Callahan et al 2008;Strain et al 2012) but rarely for other treatments, such as psychotropic medications or parent training (PT) (Tierney et al 2007). The latter objective, determining satisfaction with the research experience, is important in three ways: Helping to ensure that the study is ethical, supporting recruitment, and making study participation as pleasant as possible.…”

“…All questionnaire respondents reported a positive experience in the study, and community members reported that participants on risperidone displayed fewer problem behaviors than did participants on placebo. Tierney et al (2007), surveyed caregivers of 96 of 101 participants with ASD in a trial of risperidone and placebo for managing highly irritable and disruptive behavior. Overall satisfaction with the study was very high, as 90.5% of caregivers indicated that they would rejoin the study if they had the option to do so.…”

“…We employed a previously used questionnaire to evaluate caregiver satisfaction in CHARTS (Tierney et al 2007). The meaning of questionnaire items remained the same although, where necessary, we made slight modifications so that all items made sense in the context of the CHARTS study.…”