Emotional Regulation Clinical Trial
Official title:
Examining the Impacts of Parent Mightier Play as a Supplement to Child Mightier Play
NCT number | NCT05080647 |
Other study ID # | 995MIGH21 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 20, 2021 |
Est. completion date | June 7, 2022 |
Verified date | October 2021 |
Source | Neuromotion Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized controlled trial comparing a group in which only child participants play Mightier video games for 8 weeks (Child Play group) to a group in which child and parent participants play Mightier video games for 8 weeks (Child and Parent Play group).
Status | Completed |
Enrollment | 41 |
Est. completion date | June 7, 2022 |
Est. primary completion date | March 19, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - Age 6-12 at the time of screening - Regular access to WiFi (for Mightier gameplay device connection) Exclusion Criteria: - Prior Mightier use - Diagnosed Intellectual Disability (by history) - Planned medication changes during the 8-week study period |
Country | Name | City | State |
---|---|---|---|
United States | Neuromotion Labs | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Neuromotion Labs |
United States,
Bjureberg J, Ljótsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjärehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. Epub 2015 Sep 14. — View Citation
Nock, M.K., Ferriter, C. & Holmberg, E. Parent Beliefs about Treatment Credibility and Effectiveness: Assessment and Relation to Subsequent Treatment Participation. J Child Fam Stud 16, 27-38 (2007). https://doi.org/10.1007/s10826-006-9064-7
RC Pianta - Unpublished measure, University of Virginia, 1992
Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012 Nov;53(11):1109-17. doi: 10.1111/j.1469-7610.2012.02561.x. Epub 2012 May 10. — View Citation
Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in child behavior and emotion problems measured on BFS at Week 8 | Behavior and Feelings Survey (BFS): The BFS (Weisz et al., 2014) is a 12-item scale measuring child behavior and emotion problems. The child's parent is prompted to read the survey questions to the child and to note the child's responses. The researcher will screen share the BFS form and record child responses in the form. Children will complete the BSF at baseline and Week 8. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Three scale scores can be derived: Internalizing Problems (sum of items 1-6), Externalizing Problems (sum of items 7-12), and Total Problems (sum of items 1-12). | Baseline and Week 8 | |
Primary | Change in child irritability from baseline measured on ARI-P at Week 8 | Affective Reactivity Index-Parent Report (ARI-P): The ARI is a 7-item scale that consists of 6 symptom items and 1 impairment item. The scale was designed to determine irritable mood rather than behavioral consequences such as hostility and acts of aggression (Stringaris et al., 2012). The individual items are scored 0,1, 2, and only the first six items are summed to form the total score, with a minimum score of 0 and a maximum score of 18, and higher scores indicating greater severity of irritability symptoms. The seventh item is an impairment item and it is analysed separately, with a minimum score of 0 and a maximum score of 3, and higher scores indicating greater irritability symptom severity. Parent participants will complete the ARI-P at baseline and Week 8. | Baseline and Week 8 | |
Primary | Parent perception of change in child emotion regulation from baseline measured on GIS at Week 8 | Global Improvement Scale (GIS): The GIS is a parent self-report question that asks parents if they have noticed any overall improvements in their child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. Minimum score = 1, Maximum score = 7, with higher numbers indicating less improvement, or worsening. The GIS has not been scientifically validated. Parent participants will complete the GIS at Week 8. | Baseline and Week 8 | |
Secondary | Change in parent emotion regulation from baseline measured on DERS-18 at Week 8 | Difficulties in Emotion Regulation Scale, 18-question short form (DERS-18): The DERS-18 (Victor & Klonsky, 2016) is an 18-question measure of the respondent's emotion regulation experiences. For scoring, three responses are reverse-coded then all responses are summed, resulting in an overall score and scores on 6 subscales: Awareness, Clarity, Goals, Impulse, Nonacceptance, and Strategies. Higher scores indicate greater emotion regulation difficulties. Parent participants will complete the DERS-18 at baseline and Week 8. | Baseline and Week 8 | |
Secondary | Change in parent beliefs about intervention credibility and effectiveness from baseline, measured on the CEQ-P at Week 4 and Week 8 | Credibility and Expectancies Questionnaire - Parent Version (CEQ-P): Parent participants will respond to the CEQ-P (Nock et al., 2007), a 6-question assessment of their beliefs about credibility and effectiveness of the intervention, at baseline, Week 4, and Week 8. Items 1, 2, 3, and 5 are scored on a nine-point scale (1 = not a lot / not much; 9 = a lot / very much). Items 4 and 6 are scored on an 11-point scale (e.g., 0-100%), then recoded for scoring to correspond to the 1-9 point scale used for items 1-3 and 5, collapsing the values from 40-60% into one value, 5. | Baseline, Week 4, and Week 8 | |
Secondary | Change in child-parent relationship from baseline, measured on the CPRS-SF at Week 8 | Child-Parent Relationship Scale (CPRS-SF): The CPRS-SF (Pianta, 1992) is a 15-item self-report instrument completed by parents that assesses their perceptions of their relationship with their child. The 15 items are rated on 5-point Likert scales. It is applicable to children ages 3-12. The CPRS-SF is scored in two subscales: an 8-item Conflict subscale (minimum score = 8, maximum score = 40, higher score indicates greater conflict), and a 7-item Closeness subscale (minimum score = 7, maximum score = 35, with greater score indicating greater closeness). Parent participants will complete the CPRS-SF at baseline and Week 8. | Baseline and Week 8 |
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