Evaluating additive effects of including canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in youth with autism spectrum disorder

评估将犬类纳入“共同调节：解决患有自闭症谱系障碍的青少年情绪失调的团体治疗”的附加效应

• 批准号: 10531772
• 负责人: Rebecca Shaffer
• 金额: $ 68.36万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10531772
• 关键词: Address; Affect; Age; Animals; Area; Arousal; Attention; Attention deficit hyperactivity disorder; Awareness; Behavior; Behavior Therapy; Canis familiaris; Cardiovascular system; Caregivers; Child; Cognitive; Cognitive Therapy; Colorado; Control Groups; Critiques; Data; Data Collection; Distal; Drops; Educational Curriculum; Emotional; Emotions; Employment; Equipment and supply inventories; Evidence based intervention; Family; Feeling suicidal; Funding Opportunities; Heart Rate; Hospitalization; Human; Hyperactivity; Impairment; Intervention; Intervention Studies; Knowledge; Learning; Link; Longevity; Measurement; Measures; Mental Health Services; Methods; Minority Groups; Modality; Modification; Motivation; National Institute of Child Health and Human Development; Outcome; Outcome Measure; Outpatients; Parents; Pediatric Hospitals; Personal Satisfaction; Pharmaceutical Preparations; Physiological; Population; Problem behavior; Process; Public Health; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Role; School-Age Population; Schools; Site; Symptoms; Techniques; Testing; Therapeutic; Training; Treatment Efficacy; Work; Youth; adolescent with autism spectrum disorder; animal efficacy; autism spectrum disorder; autistic children; base; caregiver stress; college; data standards; dysphoria; emotion dysregulation; emotion regulation; executive function; experience; flexibility; follow-up; heart rate variability; hospitalization rates; improved; individuals with autism spectrum disorder; learning materials; mindfulness; minority children; negative affect; outpatient programs; patient population; peer; post intervention; programs; psychologic; satisfaction; secondary outcome; skills; social skills; success; treatment group

Project Summary/Abstract The primary objective of this R01 application is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). ED in youth with ASD has been linked to significantly higher rates of psychiatric hospitalizations, suicidal ideation, use of psychotropic medications, school disciplinary actions, peer rejection, failed college and employment transitions, and poorer quality of life. Our group developed Regulating Together (RT), an intensive group-based treatment with a concurrent parent group that employs evidence-based intervention techniques of cognitive behavioral therapy, parent training, and mindfulness and acceptance-based therapy. Preliminary evidence for its feasibility and efficacy has been demonstrated, including reductions in emotional reactivity and dysphoria and increases in heart rate variability and cognitive flexibility at 10-weeks following intervention. Despite this, change did not occur immediately post intervention. Animal Assisted Interventions (AAI) have emerged as a promising approach for youth with ASD, demonstrating improvements in irritability, hyperactivity, positive affect, and quality of life. AAI also has shown to increase in-session engagement and learning. Yet, AAI has not yet been utilized to systematically target ED in ASD nor has it been examined in conjunction with a manualized intervention. In the current study, we propose a multi-site randomized clinical trial of RT with and without a canine present to evaluate its immediate and longer-term efficacy. In 240 youth (ages 8-12 years) with ASD, we will assess RT with AAI (RT-Canine) and without AAI (RT-Standard) on primary ED symptom of reactivity, and secondary outcomes, including dysphoria, caregiver stress, cognitive flexibility, mindfulness awareness, and emotion regulation skills knowledge. We hypothesize that the canines will increase therapeutic engagement measured through alliance, motivation, and improved behavior, which will then increase intervention session level learning, and ultimately immediate and long-term intervention outcomes. Furthermore, based on our preliminary evidence, we also will explore an objective outcomes measure of heart rate/heart rate variability and its relationship to engagement, learning, and ED symptom outcomes. This proposal is relevant to the NICHD Human-Animal Interaction funding opportunity by addressing the critical public health issue of ASD through examination of AAI efficacy by utilizing standardized data collection outcome methods. In addition, we closely address protection for both the canines and the youth with ASD throughout the proposal. Finally, we will make a concerted effort to include youth from minority groups, as emphasized in the FOA. Ultimately, findings from our study have the potential to expand both ASD and AAI research, with immense impact on the well-being and outcomes of youth with ASD as evidence-based interventions for ED in this population is a critical gap in mental health care.

Project Summary/Abstract The primary objective of this R01 application is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). ED in youth with ASD has been linked to significantly higher rates of psychiatric hospitalizations, suicidal ideation, use of psychotropic medications, school disciplinary actions, peer rejection, failed college and employment transitions, and poorer quality of life. Our group developed Regulating Together (RT), an intensive group-based treatment with a concurrent parent group that employs evidence-based intervention techniques of cognitive behavioral therapy, parent training, and mindfulness and acceptance-based therapy. Preliminary evidence for its feasibility and efficacy has been demonstrated, including reductions in emotional reactivity and dysphoria and increases in heart rate variability and cognitive flexibility at 10-weeks following intervention. Despite this, change did not occur immediately post intervention. Animal Assisted Interventions (AAI) have emerged as a promising approach for youth with ASD, demonstrating improvements in irritability, hyperactivity, positive affect, and quality of life. AAI also has shown to increase in-session engagement and learning. Yet, AAI has not yet been utilized to systematically target ED in ASD nor has it been examined in conjunction with a manualized intervention. In the current study, we propose a multi-site randomized clinical trial of RT with and without a canine present to evaluate its immediate and longer-term efficacy. In 240 youth (ages 8-12 years) with ASD, we will assess RT with AAI (RT-Canine) and without AAI (RT-Standard) on primary ED symptom of reactivity, and secondary outcomes, including dysphoria, caregiver stress, cognitive flexibility, mindfulness awareness, and emotion regulation skills knowledge. We hypothesize that the canines will increase therapeutic engagement measured through alliance, motivation, and improved behavior, which will then increase intervention session level learning, and ultimately immediate and long-term intervention outcomes. Furthermore, based on our preliminary evidence, we also will explore an objective outcomes measure of heart rate/heart rate variability and its relationship to engagement, learning, and ED symptom outcomes. This proposal is relevant to the NICHD Human-Animal Interaction funding opportunity by addressing the critical public health issue of ASD through examination of AAI efficacy by utilizing standardized data collection outcome methods. In addition, we closely address protection for both the canines and the youth with ASD throughout the proposal. Finally, we will make a concerted effort to include youth from minority groups, as emphasized in the FOA. Ultimately, findings from our study have the potential to expand both ASD and AAI research, with immense impact on the well-being and outcomes of youth with ASD as evidence-based interventions for ED in this population is a critical gap in mental health care.