Anxiety Clinical Trial
Official title:
Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
NCT number | NCT04059939 |
Other study ID # | RHD087706A |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2017 |
Est. completion date | January 2022 |
Despite decades of research on reading disabilities, little is known about improving reading in the middle grades (i.e., grades 3-6) and advancements have been hindered by the narrow focus on reading problems alone without acknowledgement of non-academic factors shown to affect learning (e.g., child self-regulation). This proposal employs a highly innovative approach aimed at improving intervention outcomes through the integration of evidence-based practices for addressing reading, as well as self-regulation/socioemotional skills, difficulties known to occur in a substantial percentage of struggling readers and to negatively influence academic performance. This project represents translational research that directly informs the practice community (schools, clinicians, teachers, parents), by identifying novel instructional practices that can be aggregated to more effectively influence student outcomes and reduce disparities in academic and socioemotional domains.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 14 Years |
Eligibility |
Inclusion Criteria: - Students enrolled in the 3rd or 4th grade - Demonstrate difficulty with reading (which is defined as scoring at or below a standard score of 90 on the Gates MacGinite Reading Comprehension Test - Difficulty with reading must be confirmed by classroom teacher/school Exclusion Criteria: - Students with limited English proficient (due to all assessments being administered in English only) - Students in life skills classes (due to task appropriateness) - Students who have an unrelated neurological disorder (e.g., tumor, traumatic brain injury) - Students who have a severe psychiatric disorder that prevents assessment (e.g., autism), or who have an uncorrected sensory disorder |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus | University of Texas at Austin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test of Word Reading Efficiency | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | ||
Primary | Multidimensional Anxiety Scale for Children | 39-item scale of anxiety comprised of four subscales: Physical Symptoms, Harm Avoidance, Social Anxiety, and Separation/Panic. Response options range from 0-3. A total score is comprised of all subscales added together. The total score can range from 0-117. The range of the subscales are as follows: Physical Symptoms (0-36), Harm Avoidance (0-27), Social Anxiety (0-27), Separation/Panic (0-27). Higher scores indicate more anxiety. There are child, parent, teacher versions of this scale. | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Primary | Woodcock-Johnson Psycho-Educational Test Battery-III | Two subtests: Letter-Word Identification and Word Attack. Scores are reported as standard scores in a range of 0-200+ or percentile ranks in a range of 0.1 to 99.9. The higher the score the greater the achievement level of the student. | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Children's Test Anxiety Scale | 30-item scale with a 4-point Likert Scale (1-4). Scale ranges from 30-120 with higher scores indicating greater test anxiety. | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Reading Anxiety Scale | 6-item scale adapted from the Wigfield and Meece (1988) Math Anxiety Scale. Designed to assess worries and stressed feelings about reading instruction and reading tests. Participants responded to each item with a 5-point Likert Scale from Never to Always. Higher scores indicate greater levels of reading anxiety. | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Attention | child attention scale, Effortful Control-Persistence/Low Distractibility subscale, Strength and Weaknesses of Attention-Deficit/Hyperactivity Disorder, parent/teacher reported attention | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Test of Silent Word Reading Efficiency and Comprehension | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | ||
Secondary | Dynamic Indicators of Basic Early Literacy Skills | Oral Reading Fluency | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Beck Anxiety Inventory | Self-report measure of anxiety in the past month. 21-item scale with a 4-point Likert scale from 0-3. Items summed together. Scale range from 0-63. Score of 0-21= low anxiety. Score of 22-35 = moderate anxiety. Score of 36 and above = potentially concerning levels of anxiety. Administered to parents. | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Beck Youth Inventories | Self-report measure comprised of five inventories, which measure depression, anxiety, anger, disruptive behavior, and self-concept. Each inventory has 20-items which are scored on a 4-point Likert scale (0-3). Higher scores indicate greater amounts of concept (i.e., depression, anxiety, anger, disruptive behavior, and self-concept) being measured. | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Stress management skills evaluation | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | ||
Secondary | Confusion, Hubbub, and Order Scale (CHAOS Survey) | 15-items with a 4-point Likert Scale (1-4) measuring the home environment. Completed by parent/caregiver. Total score is created by summing the responses to the items. Range is 15-60. Higher scores indicate more chaotic home environments. | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Reading Comprehension | Kaufman Test of Educational Achievement-III (KTEA-3) | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Fluency/Comprehension | Test of Silent Word Reading Fluency | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Verbal Knowledge/Matrices | Kaufman Brief Intelligence Test | Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3 | |
Secondary | Math Calculation | Woodcock-Johnson Psycho-Educational Test Battery-III Calculation | Change from baseline to post-intervention year 2 | |
Secondary | Essential Word Knowledge | Change from baseline to post-intervention year 2 | ||
Secondary | Reading Comprehension | Gates-MacGinitie Reading Comprehension | Change from post-intervention year 1 to post-intervention year 2 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
Completed |
NCT05881681 -
A Mindfulness Approach to UA for Afro-descendants
|
N/A | |
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Active, not recruiting |
NCT04961112 -
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
|
N/A | |
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Completed |
NCT05980845 -
The Effect Nature Sounds and Music on Hemodialysis Patients
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Completed |
NCT05585749 -
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
|
N/A | |
Terminated |
NCT03272555 -
WILD 5 Wellness: A 30-Day Intervention
|
N/A | |
Recruiting |
NCT05997849 -
Development of a Multiplatform Mental Health Mobile Tool
|
N/A | |
Completed |
NCT06421233 -
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
|
N/A |