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An Integrative Intervention for Preventing Children's Emotional Disorders

An Integrative Intervention for Preventing Children's Emotional Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05424900
Enrollment
294
Registered
2022-06-21
Start date
2021-05-03
Completion date
2022-09-30
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Problem

Keywords

online therapeutic game, emotional problems, prevention

Brief summary

The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms.

Detailed description

The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms. The game will be used by children and adolescents for a period of four weeks. Pre-test and post-test measurements will be taken.

Interventions

BEHAVIORALRethink game

REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.

Sponsors

The Executive Agency for Higher Education, Research, Development and Innovation Funding
CollaboratorOTHER
Oana David
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* children aged 8 to 12 years * parental consent provided * al least one answer different than never true on the Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein & Fink, 1998; Bernstein et al., 2003), measuring dichotomically the presence of Emotional Neglect, Physical Neglect, Emotional Abuse, Physical Abuse

Exclusion criteria

* intellectual disability or physical limitations precluding the use of the online platform presence of a mental health disorder in the children or their enrolled parent

Design outcomes

Primary

MeasureTime frameDescription
Child emotion regulationbaseline; pre-intervention (one week before the intervention)The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 strong disagreement to 5strong agreement where higher scores represent better emotional regulation abilitie
Changes in child emotion regulationpost-test, one week after the interventionThe Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 strong disagreement to 5strong agreement where higher scores represent better emotional regulation abilities.
Children emotional regulationbaseline; pre-intervention (one week before the intervention)The Cognitive Emotion Regulation Questionnaire - Short (Garnefski & Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
Changes in children emotional regulationpost-test, one week after the interventionThe Cognitive Emotion Regulation Questionnaire - Short (Garnefski & Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
child emotional simptomsbaseline; pre-intervention (one week before the intervention)SDQ - Strengths and Difficulties Questionnaire Goodman R, Meltzer H, Bailey V (1998)
Changes in child emotional simptomspost-test, one week after the interventionSDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998)

Secondary

MeasureTime frameDescription
Changes child mental healthpost-test, one week after the interventionSDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130
child behavioral difficultiesbaseline; pre-intervention (one week before the intervention)SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130
Mental healthbaseline; pre-intervention (one week before the intervention)SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130
Children's irrational beliefsbaseline; pre-intervention (one week before the intervention)The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999)
changes in Children's irrational beliefspost-test, one week after the interventionThe Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999)

Other

MeasureTime frameDescription
Child attachmentbaseline; pre-intervention (one week before the intervention)The Security Scale (Kerns, Klepac, & Cole, 1996) is a 15-item measure of attachment security in children aged 8 to 12. The scale uses a some kids... other kids... format and asks respondents to select the degree to which they feel they are similar to the type of children they have previously selected, using a two-point Likert scale (Really true for me or Sort of true for me.
Child traumabaseline; pre-intervention (one week before the intervention)CTQ - Childhood Trauma Questionnaire Bernstein, D. P., Stein, J. A., Newcomb, M. D., Walker, E., Pogge, D., Ahluvalia, T., ... & Zule, W. (2003). Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child abuse & neglect, 27(2), 169-190.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026