Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in LOC-E episode frequency |
This will be measured using the Child Version of the Eating Disorder Examination (ChEDE C.1; Bryant-Waugh et al., 1996; Bryant-Waugh, 2020). The EDE 17.0D (Fairburn et al., 2014), which measures eating disorder symptom severity, has been modified for use with children ages 8 and above (Bryant-Waugh et al., 1996; Bryant-Waugh, 2020). The ChEDE has been shown to have high inter-rater reliability and internal consistency (Hilbert et al., 2013; Watkins et al., 2005). For the purposes of this study, only diagnostic item 11 (identifying bulimic episodes and other episodes of overeating) of the ChEDE will be used, which included questions regarding feelings of loss of control eating, features associated with binge eating, and distress about binge eating. The measure will be used for diagnostic assessment of LOC-E for study inclusion purposes, and at Baseline and 3-Month Follow-Up to establish LOC-E episode frequency. |
Screening, Baseline, 3 Months |
|
| Secondary |
Change in eating behaviour |
This will be measured at Baseline and 3-Month Follow-Up using the Child Eating Behaviour Questionnaire (CEBQ; Wardle et al., 2001). The CEBQ, to be completed by the parent/guardian, is a valid and reliable 35-item measured used to evaluate cognitions, emotions, and behaviors associated with disordered eating, rated on a 5-point Likert scale with scores ranging from 1 (never) to 5 (always). Higher scores indicate a greater global level of disordered eating (Wardle et al., 2001; Carnell & Wardle, 2007). |
Baseline, 3 Months |
|
| Secondary |
Change in disordered eating |
This will be measured at Baseline and 3-Month Follow-Up using the Eating Disorder Examination Questionnaire adapted for children (ChEDE-Q8; Kliem et al., 2017).The ChEDE-Q8 is valid self-report version of the ChEDE, evaluating areas of eating disorder psychopathology, with scores on the 8-item measure ranging from 0 (absent) to 6 (extreme everyday presence) with high internal consistency (Kliem et al., 2017). Higher scores indicate higher levels of eating disorder psychopathology. |
Baseline, 3 Months |
|
| Secondary |
Change in ADHD symptom severity |
This will be measured using the Vanderblit ADHD Diagnostic Parent Rating Scale (VADPRS; Wolraich et al., 2003), a 56-item measure used to evaluate ADHD behaviors, along with academic and social performance in children to be completed the parent/guardian. The ADHD symptoms has scores ranging from 0 (never) to 3 (very often) on a 4-point Likert scale, with higher scores indicating greater levels of ADHD behaviours. The performance component has scores ranging from 1 (excellent) to 5 (problematic) on a 5-point scale, with higher scores indicating greater impairment in academic and/or social performance. This will be administered at Baseline and with an adapted/shortened version at a 3-Month Follow-Up. The VADPRS has demonstrated good construct, discriminant, and content validity, as well as internal consistency (Wolraich et al., 2003; Collett et al., 2003; Wolraich et al., 2013; Bard et al., 2013). |
Baseline, 3 Months |
|
| Secondary |
Change in Impulsivity and reward sensitivity |
This will be measured by the Parent-Report Behavioral Inhibition System/Behavioral Activation System Scales (BIS/BAS; Vervoort et al., 2015) at Baseline and 3-Month Follow-Up. This 20-item parent-report measure, which was adapted from the original self-report BIS/BAS scales (Carver & White, 1994), examines two motivational systems through responses to reward and punishment. Impulsivity has been found to be positively correlated with BAS-drive and BAS-fun seeking, and negatively correlated with BIS (Franken et al., 2005); therefore, the BIS/BAS can be used as a proxy for impulsivity in youth. Scores range from 1 (not true at all) to 4 (all true) on a 4-point Likert scale. The total separate scores of the four subscales will be used, with higher scores indicating greater levels of sensitivity in the associated motivational system. The parent-report BIS-BAS is a reliable and valid tool for examining punishment and reward sensitivity in children (Vervoort et al., 2015). |
Baseline, 3 Months |
|
| Secondary |
Change in anxiety/mood severity |
This will be measured using the Revised Child Anxiety and Depression Scale - Short Version (RCADS-25; Ebesutani et al., 2012) at Baseline and 3-Month Follow-Up. This 25-item self-report measure, adapted from the original 47-item RCADS (Chorpita et al., 2000; Chorpita et al., 2005), is used to assess depression and anxiety symptoms in children. The RCADS-25 contains 10 questions based on major depressive disorder, and 15 questions based on five DSM-IV anxiety domains: separation anxiety disorder, generalized anxiety disorder, panic disorder, social phobia, and obsessive-compulsive disorder. RCADS-25 scores range from 0 (never) to 3 (always) on a 4-point Likert scale. Global anxiety and depression scores will be used separately, with higher scores on each scale indicating greater levels of anxiety and depression. The RCADS-25 is a reliable clinical tool and has been shown to have discriminant, convergent, and divergent validity (Ebesutani et al., 2017). |
Baseline, 3 Months |
|
| Secondary |
Parental/Guardian LOC-E |
This will be measured using the LOCES (Latner et al., 2014), which is to be completed by parents/guardians at Baseline in relation to their own eating psychopathology. This 24-item self-report measure used to examine three aspects of LOC-E: behavioural, cognitive/dissociative, and positive/euphoric. The LOCES consists of three subscales based on the three aspects of LOC-E, with scores ranging from 1 (never) to 5 (always) on a 5-point Likert scale. The global mean score calculated from the average of each subscale will be used, with higher scores indicating greater levels of LOC-E. The LOCES has been shown to have high internal consistency, convergent and discriminant validity, and test-retest reliability (Latner et al., 2014). |
Baseline |
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