NCT03308981

Brief Summary

This study aims to test the efficacy of the REThink therapeutic online video game. Children and adolescents (N = 150), aged between 10-16 years, will be randomly assigned to one of three groups: 1) REThink group, 2) Rational-Emotive-Behavioral Education (REBE) group and 3) wait-list condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

September 27, 2017

Last Update Submit

January 17, 2018

Conditions

Resilience, Psychological

Keywords

therapeutic online gameresiliencepreventionemotional disorderschildadolescent

Outcome Measures

Primary Outcomes (2)

  • Emotional symptoms

    Strengths and Difficulties Questionnaire - child version (SDQ; Goodman, 1997)

    12 months

  • Depressed mood

    The Early Adolescent Temperament Questionnaire - Revised (EATQ-R; Ellis, 2002)

    12 months

Secondary Outcomes (4)

  • Emotion-regulation

    12 months

  • Temperament

    12 months

  • Negative and positive emotions

    12 months

  • Satisfaction with the intervention

    12 months

Other Outcomes (5)

  • Irrational beliefs

    12 months

  • Automatic Thoughts

    12 months

  • Anxiety in a stressful situation

    12 months

  • +2 more other outcomes

Study Arms (3)

REThink therapeutic online game

EXPERIMENTAL

REThink group will play twice the seven levels of the game, divided into seven modules.

Device: REThink therapeutic online game

REBE group

ACTIVE COMPARATOR

Participants will follow 7 modules, structured based on the strategies practiced in each of the REThink level.

Other: REBE group

Wait-list

NO INTERVENTION

Participants will not receive any intervention.

Interventions

REThink therapeutic online gameDEVICE

The REThink therapeutic online game has seven levels. Each level has various degrees of complexity, which increase as the player progresses in the game. The scenario of the game was developed based on the REBT model, such that it focuses on: a. identifying the emotional and behavioral reactions; b. identifying cognitive processes; c. identifying the relation between cognitive processes and emotions and behavioral reactions; d. changing irrational cognitions into rational cognitions; e. building problem solving skills; f. building relaxation skills and g. building happiness skills.

REThink therapeutic online game
REBE groupOTHER

In the Rational-Emotive-Behavioral Education (REBE) group participants will follow 7 modules, structured based on the strategies practiced in each of the REThink level.

REBE group

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • aged between 10-16 years
  • provided written parental consent

You may not qualify if:

  • Intellectual disability or physical limitations precluded the use of the computer program
  • Had a major mental health disorder
  • Had had (in past three months) or was having psychotherapy or psychiatric treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy

Cluj-Napoca, 400015, Romania

Location

Related Publications (3)

  • David OA, Fodor LA. Are gains in emotional symptoms and emotion-regulation competencies after the REThink therapeutic game maintained in the long run? A 6-month follow-up. Eur Child Adolesc Psychiatry. 2023 Oct;32(10):1853-1862. doi: 10.1007/s00787-022-02002-w. Epub 2022 May 20.

    PMID: 35593966DERIVED

  • David OA, Cardos RAI, Matu S. Is REThink therapeutic game effective in preventing emotional disorders in children and adolescents? Outcomes of a randomized clinical trial. Eur Child Adolesc Psychiatry. 2019 Jan;28(1):111-122. doi: 10.1007/s00787-018-1192-2. Epub 2018 Jul 10.

    PMID: 29992353DERIVED

  • David OA, Cardos RAI, Matu S. Changes in irrational beliefs are responsible for the efficacy of the REThink therapeutic game in preventing emotional disorders in children and adolescents: mechanisms of change analysis of a randomized clinical trial. Eur Child Adolesc Psychiatry. 2019 Mar;28(3):307-318. doi: 10.1007/s00787-018-1195-z. Epub 2018 Jul 9.

    PMID: 29987559DERIVED

Study Officials

  • Oana A David, PhD

    Babes-Bolyai University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three groups: 1) REThink group, 2) Rational-Emotive-Behavioral Education (REBE) group and 3) wait-list condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Oana David

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 13, 2017

Study Start

September 15, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)