Authors
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Tablon, Paula -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2017
INTERVENTION: Random assignment will occur after baseline assessment is complete. Once participants are deemed eligible for the study (following in‐person screening) they are randomized to treatment immediately or waitlist control condition using a randomly generated list obtained from the following site: https://www.randomizer.org/ Half of the children will be assigned to the treatment condition immediately (provided with the emotion regulation training program immediately after the initial assessments), and the other half will be assigned to the waitlist control condition (asked to wait 12 weeks before receiving the intervention). The program involves ten 1‐hour weekly sessions, where the youth and a parent will meet with a therapist for one‐on‐one therapy. During these sessions, the youth will participate in an assortment of activities including computer games, problem solving tasks, role playing, and working with their parent and therapist. They also will get some brief homework tasks to help generalize what they are learning. The focus of all of these activities is to help build emotion regulation skills. CONDITION: Neurodevelopmental disorders (autism spectrum disorders, fetal alcohol spectrum disorder, cerebral palsy, learning disability, or attention deficit hyperactivity disorder) ; Mental and Behavioural Disorders PRIMARY OUTCOME: 1. Child mental health problems: ; 1.1. Emotional disorders, measured using the Anxiety Disorders Interview Schedule: Child and Parent Interview‐4th Edition (ADIS‐C/P‐IV); 1.3. Child behaviour and emotions, measured using the Behavior Assessment System for Children, Third Edition (BASC‐3); 1.2. Child illness severity, global improvement/change and therapeutic response, measured using the Clinical Global Impression–Severity and –Improvement (CGI‐Severity, CGI‐Improvement); ; All measures will be collected at the following time points for the treatment immediate group: baseline (Time 1), 12 weeks post baseline (Time 2) and follow‐up (12‐weeks post Time 2). For the waitlist control group, data will be collected at baseline (Time 1), 12 weeks later (Time 2), post intervention (Time 3) and 12‐weeks post intervention (Time 4). With the exception of WRAT‐4, which will only be completed at Time 1. INCLUSION CRITERIA: 1. Age 8‐13 years 2. Diagnosis of a neurodevelopmental disorder (autism spectrum disorder, fetal alcohol spectrum disorder, cerebral palsy, learning disability, or attention deficit hyperactivity disorder) 3. FSIQ > 80 (WASI‐II; Weschler, 2011) 4. At least one co‐occurring anxiety or mood disorder SECONDARY OUTCOME: Child Report Measures: ; 1. Child emotion regulation, measured using the Children’s Emotion Management Scales (CEMS); 2. Child acceptance and mindfulness, measured using the Child & Adolescent Mindfulness Measure (CAMM); 3. Child social problem‐solving, measured using James and the Math Test and Dylan is Being Teased; 4. Child emotion regulation, measured using the Computerized Mirror Tracing Performance Task (2013); ; Parent Report Measures:; 1. Parents’ expressed emotion, measured using the Five Minute Speech Sample (FMSS); 2. Child emotion regulation, measured using the Emotion Regulation Checklist (ERC); 3. Child emotion regulation and social skills, measured using the Emotion Regulation and Social Skills Questionnaire ‐ Parent (ERSSQ‐P); 4. Quality of the parent‐child relationship, measured using the Positive Affect Index (PAI); 5. Child adjustment and psychopathology, measured using the Strength and Difficulties Questionnaire (SDQ); 6. Child health‐related quality of life, measured using KIDSCREEN; ; Parent Child Dyad:; 1. Parent and child emotion regulation and socialization, measured using the Emotion Discussion Task (EDT); ; All measures will be collected at the following time points for the treatment immediate group: baseline (Time 1), 12 weeks post baseline (Time 2) and follow‐up (12‐weeks post Time 2). For the waitlist control group, data will be collected at baseline (Time 1), 12 weeks later (Time 2), post intervention (Time 3) and 12‐weeks post intervention (Time 4). With the exception of WRAT‐4, which will only be completed at Time 1.
Epistemonikos ID: bc48729132c18741fc7ac59d43b9d0d5ad5013cb
First added on: Aug 23, 2024