Primary PreventionNCT02653586
Prevention Program Promoting Self Resilience,Positive Self-Image and Body Image Among Adolescence Aged 15-17
A study testing program "In Favor of Resilience Self" in people with Primary Prevention, run by Tel Hai College.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention
- What is being tested?
- program "In Favor of Resilience Self"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants who filled out the questionnaires before and after the program, and if their parents have signed a letter of agreement
Who cannot join
- Participants who do not completed the questionnaires at least twice
About this study
Official title: "In Favor of Resilience Self" Prevention Program Promoting Positive Self-Image and Body Image Among Adolescence Aged 15-17
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.
Read the detailed description
Participants and setting Two high schools were recruited for the study, in each school classes from grades 9th and 10th were chosen to participate in the study all mixed gender classes. The two high schools are in northern Israel, one in a rural area and the second in a small city, both serving the Jewish population. The size of the schools were similar. All data were collected within the school setting.
Program description "Towards a more resilient self" is an interactive, cognitive behavior program aiming to address low resilience, low self-esteem and body dissatisfaction. The program contains a range of coping strategies to help adolescents improve resilience, self-esteem and body image. The program consists of nine 90-min sessions delivered by one group leader in the presence of the classes' teachers. Participants in the control group received one session of 90 minutes with health nutrition education.
- Conditions
- Primary Prevention
- Being tested
- program "In Favor of Resilience Self"
- Keywords
- resilience, prevention program, body image, self esteem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
program "In Favor of Resilience Self"Other
Also called "In Favor of myself"
A prevention program aiming at improve self-resilience ,self-esteem and body image, contains nine interactive activities, based on a cognitive dissonance method.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured three times during six months, measuring a change in rosenberg self esteem scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Responsible party
- Principal investigator, shani aboutboul, Tel Hai College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653586
- Sponsor's protocol ID
- telhaicolege
- Status last verified
- May 2017
- First submitted
- 3 Jan 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29912918
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "In Favor of Resilience Self" Prevention Program Promoting Positive Self-Image and Body Image Among Adolescence Aged 15-17
- ClinicalTrials.gov ID
- NCT02653586
- Acronym / sponsor ID
- telhaicolege
- Conditions
- Primary Prevention
- Keywords
- resilience, prevention program, body image, self esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants and setting Two high schools were recruited for the study, in each school classes from grades 9th and 10th were chosen to participate in the study all mixed gender classes. The two high schools are in northern Israel, one in a rural area and the second in a small city, both serving the Jewish population. The size of the schools were similar. All data were collected within the school setting.
Program description "Towards a more resilient self" is an interactive, cognitive behavior program aiming to address low resilience, low self-esteem and body dissatisfaction. The program contains a range of coping strategies to help adolescents improve resilience, self-esteem and body image. The program consists of nine 90-min sessions delivered by one group leader in the presence of the classes' teachers. Participants in the control group received one session of 90 minutes with health nutrition education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| program "In Favor of Resilience Self" | Experimental | Other: program "In Favor of Resilience Self"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. |
| 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants who filled out the questionnaires before and after the program, and if their parents have signed a letter of agreement
Key exclusion criteria (1 listed)
- Participants who do not completed the questionnaires at least twice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| program "In Favor of Resilience Self"Also: "In Favor of myself"A prevention program aiming at improve self-resilience ,self-esteem and body image, contains nine interactive activities, based on a cognitive dissonance method. | Other | program "In Favor of Resilience Self" |
Primary outcome
The Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Measured three times during six months, measuring a change in resilience scale
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"
Rosenberg self esteem scale
Time frame: Measured three times during six months, measuring a change in 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Derived from this study: PubMed 29912918Agam-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing program "In Favor of Resilience Self" in people with Primary Prevention, run by Tel Hai College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Connor-Davidson Resilience Scale (CD-RISC) (time frame: Measured three times during six months, measuring a change in resilience scale). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.