NCT02653586

Brief Summary

The study was a group randomized controlled trial. Within each school Classes of high school students were allocated by randomization to the intervention or control group by a function Randomization in Excel program. Outcomes were measured by questionnaire at pre- intervention, post-intervention and 3-month follow-up. The study protocol was approved by Tel Hai college institutional review board. Parents of all participants, in the intervention and in the control group, received information about the program and the study and were choose whether to provided informed consent or not.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

January 3, 2016

Last Update Submit

May 7, 2017

Conditions

Keywords

resilienceprevention programbody imageself esteem

Outcome Measures

Primary Outcomes (2)

  • The Connor-Davidson Resilience Scale (CD-RISC)

    The CD-RISC contains 25 items, all of which carry a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The scale is rated based on how the subject has felt over the past month. The total score ranges from 0-100, with higher scores reflecting greater resilience. Examples of questions: "Able to adapt to change", "Think of self as strong person"

    Measured three times during six months, measuring a change in resilience scale

  • Rosenberg self esteem scale

    The scale is a ten item Likert scale with items answered on a four point scale - from strongly agree- (3), agree (2), disagree (1), strongly disagree (0). The total score ranges from 0-30 The higher the score, the higher the self esteem. to strongly disagree.

    Measured three times during six months, measuring a change in rosenberg self esteem scale

Study Arms (2)

program "In Favor of Resilience Self"

EXPERIMENTAL

The program "In Favor of Resilience Self" was delivered to adolescence aged 15-17, over 2 months. The program contained nine weekly, 90-min lessons that focus on enhancing self- resilience, self-esteem, self-image, body image. All students completed a self-report questionnaire at baseline, conclusion and 3 months after program conclusion.

Other: program "In Favor of Resilience Self"

control group

NO INTERVENTION

The control group didn't receive the intervention program, instead they received a lecture on wised nutrition. In addition the control group completed the same self-report questionnaire as the intervention group at baseline, conclusion and 3 months after program.

Interventions

A prevention program aiming at improve self-resilience ,self-esteem and body image, contains nine interactive activities, based on a cognitive dissonance method.

Also known as: "In Favor of myself"
program "In Favor of Resilience Self"

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants who filled out the questionnaires before and after the program, and if their parents have signed a letter of agreement

You may not qualify if:

  • Participants who do not completed the questionnaires at least twice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Agam-Bitton R, Abu Ahmad W, Golan M. Girls-only vs. mixed-gender groups in the delivery of a universal wellness programme among adolescents: A cluster-randomized controlled trial. PLoS One. 2018 Jun 18;13(6):e0198872. doi: 10.1371/journal.pone.0198872. eCollection 2018.

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
principal investigator

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 12, 2016

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

May 9, 2017

Record last verified: 2017-05