ADHD Clinical Trial
Official title:
The Acceptability and Effectiveness of Formal Versus Informal Mindfulness Instruction Among University Students With Self-reported ADHD, Lived Experience of Nonsuicidal Self-injury, or Stress: An Online Randomized Controlled Trial
The present study will use a randomized controlled design to investigate group differences between university students with self-reported stress (comparison group), ADHD, or a history of nonsuicidal self-injury (NSSI) in response to a four-week mindfulness instruction program across conditions (formal mindfulness program, informal mindfulness program, inactive control) in terms of the intervention's acceptability and effectiveness.
As post-secondary students report increasing levels of stress and difficulty coping with the challenges of university, student services have had to consider alternative approaches to meet the demand for student support. Thus, there has been a move towards extending support beyond traditional mental health services to include the teaching of resilience-building strategies. These resilience-building activities use pedagogical principles and are commonly instructional programs offered to groups of students. These programs often use mindfulness (i.e., purposeful attention to the present moment with nonjudgmental acceptance) as a foundation due to substantial evidence of the benefits of mindfulness in university students. However, subgroups within the university student population may respond differently to standard mindfulness instruction. Indeed, emerging evidence suggests that mindfulness instruction may be experienced in unique ways by certain vulnerable populations, such as those with a history of non-suicidal self-injury (NSSI; self-injury without lethal intent) or attention-deficit/hyperactivity disorder (ADHD; neurodevelopmental disorder characterized by developmentally atypical levels of inattention and/or hyperactivity-impulsivity). Students with a history of engaging in NSSI comprise 10-39% of university students, while students with ADHD comprise 2-8% of university students. These subgroups of students tend to exhibit a vulnerability to university stressors and stand to incur important benefits from resilience-building strategies that are tailored to their needs. However, students with history of NSSI or ADHD are predisposed to find standard mindfulness instruction challenging and/or inaccessible. Standard mindfulness instruction generally consists of a combination of formal and informal practice. Formal practices can be conceptualized as structured, sustained attentional guided activities in which mindfulness is practiced within an allotted period of time (e.g., sitting meditation, body scan), whereas informal practices are brief and unstructured, and focus on the experience of one's senses during routine activities (e.g., becoming aware of the feeling of water on one's hands while washing them). Formal practice often requires sustained attention on one's inner experience (i.e., thoughts and emotions) and bodily sensations. Existing difficulties with emotion regulation, self-criticism, and a potentially complex relationship with their body may render this common component of formal mindfulness practice challenging for students with a history of NSSI. For students with ADHD, the elevated level of attentional demand required for formal mindfulness practice may be particularly challenging (e.g., ADHD). Indeed, individuals with ADHD tend to report elevated attrition rates from mindfulness-based programs. If standard mindfulness programming is not properly adapted to individual differences, this may limit its accessibility to university students with a history of NSSI or ADHD. Promising emerging evidence from our team finds that adolescents, who have difficulties with sustained attention, prefer informal mindfulness practice over formal practice. Specifically, students found the informal practices more accessible (more likely to use in future) than formal practices. This study is an important precursor to the proposed study, given that it provides reason to believe that students with ADHD, who also experience attention difficulties, might similarly find informal mindfulness more accessible. Similarly, a recent study by our team found that university students with a history of NSSI found informal mindfulness practice to be more acceptable than formal practice. Consistent with these exciting early results from our team, in a recent systematic review examining the unique benefits of informal mindfulness, it was concluded that informal practices may be more accessible and acceptable among those already experiencing difficulties with attention or emotion regulation. The need for additional studies exploring the potentially differential effectiveness of formal and informal mindfulness instruction among groups with unique intrapersonal needs was highlighted. To investigate whether the response to and associated benefit of formal or informal mindfulness instruction differs between students with a history of NSSI or ADHD, the proposed study will use a randomized controlled design to investigate group differences in both the immediate response to, and long-term benefits of, formal versus informal mindfulness instruction. Specifically, the study will assess (1) satisfaction with each mindfulness instruction type quantitatively (through surveys) and qualitatively (through semi-structured interviews), (2) changes in mental health/well-being and educational outcomes over time, across groups (i.e., NSSI, ADHD, comparison) and conditions (i.e., formal, informal), and (3) whether the impact of the instruction (i.e., formal, informal, control) on these outcomes occurs as a function of changes in specific facets of mindfulness. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
Not yet recruiting |
NCT06456372 -
Digital Health Intervention for Children With ADHD
|
N/A | |
Completed |
NCT05518435 -
Managing Young People With ADHD in Primary Care Study
|
||
Active, not recruiting |
NCT04978792 -
Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?
|
N/A | |
Completed |
NCT03216512 -
Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
|
N/A | |
Not yet recruiting |
NCT02906501 -
Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances
|
N/A | |
Completed |
NCT02900144 -
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
|
N/A | |
Completed |
NCT02829528 -
Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
|
N/A | |
Terminated |
NCT02271880 -
Improving Medication Adherence in ADHD Adolescents
|
N/A | |
Completed |
NCT02562469 -
ACTIVATE: A Computerized Training Program for Children With ADHD
|
N/A | |
Recruiting |
NCT02255565 -
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
|
Phase 4 | |
Completed |
NCT02463396 -
Mindfulness Training in Adults With ADHD
|
N/A | |
Completed |
NCT01673594 -
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
|
Phase 4 | |
Terminated |
NCT01733680 -
Amiloride Hydrochloride as an Effective Treatment for ADHD
|
Early Phase 1 | |
Completed |
NCT02300597 -
Internet-based Support for Young People With ADHD and Autism - a Controlled Study
|
N/A | |
Active, not recruiting |
NCT01137318 -
Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
|
Phase 2 | |
Completed |
NCT01404273 -
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
|
N/A | |
Completed |
NCT00586157 -
Study of Medication Patch to Treat Children Ages 6-12 With ADHD
|
Phase 4 | |
Completed |
NCT00573859 -
The Reinforcing Mechanisms of Smoking in Adult ADHD
|
Phase 1/Phase 2 | |
Completed |
NCT00228540 -
Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD
|
Phase 3 |