NCT02265978

Brief Summary

This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting positive mental health through emotional self-awareness in adolescents. Participants will be recruited from second-level schools in Ireland. Schools will be randomly assigned to the intervention or control condition. Participants in the intervention condition will use CopeSmart for a four week period. Those in the control condition will not use any mental health app.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
387

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

October 7, 2014

Last Update Submit

July 8, 2015

Conditions

Keywords

Emotional Self-AwarenessPositive CopingHelp-Seeking

Outcome Measures

Primary Outcomes (1)

  • Changes in levels of emotional self-awareness measured by the Emotional Self-Awareness Scale

    Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)

Secondary Outcomes (4)

  • Changes in frequency of use of positive coping strategies measured by the Coping Strategies Inventory

    Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)

  • Changes in levels of well-being measured by the WHO-5 Well-Being Index

    Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)

  • Changes in help-seeking behaviour measured by the General Help-Seeking Questionnaire

    Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)

  • Changes in levels of emotional distress measured by the Depression, Anxiety and Stress Scale

    Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)

Study Arms (2)

CopeSmart

EXPERIMENTAL
Device: CopeSmart

Control

NO INTERVENTION

Interventions

CopeSmartDEVICE

Participants will use the CopeSmart app at least once per day for four weeks

CopeSmart

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must be between 14 and 19 years
  • Must be enrolled in second-level education
  • Must have access to an iPhone, iTouch or Android mobile device
  • Must obtain signed parental consent to participate

You may not qualify if:

  • \- No parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

Related Publications (1)

  • Kenny R, Dooley B, Fitzgerald A. Ecological Momentary Assessment of Adolescent Problems, Coping Efficacy, and Mood States Using a Mobile Phone App: An Exploratory Study. JMIR Ment Health. 2016 Nov 29;3(4):e51. doi: 10.2196/mental.6361.

Related Links

Study Officials

  • Rachel E Kenny, M.Psych.Sc.

    University College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 16, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations