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Increasing the Effect of a School-based Prevention Program by Teacher Involvement

19 agosto 2021 aggiornato da: Tel Hai College

The Impact of School-Based Programs on the Psychological Health of Children and Youth: The Moderating Role of a Teacher Component and Internet-Delivered Content.

Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their teachers. Study hypothesis is that the intervention program will yield improvement in adolescents whose teachers participated in the program, in comparison with the adolescents whose teachers weren't involved in the intervention. Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. The study protocol was approved by Tel Hai College institutional review board. Parents of all student participants in the intervention and in the control group, as well as teachers involved in the program, received information about the program and the study and were asked to provide informed consent.

Panoramica dello studio

Descrizione dettagliata

Early adolescent (10-13 years) is characterized by hormonal changes and accelerated physiological growth. Significant risk factors for the physical and mental health of children and adolescents include, among other things, disordered eating patterns, overweight and reduced physical activity, low self-esteem and negative body image.

"In Favor of Myself" is a preventive intervention program. The program's primary goal is to increase adolescents' self-esteem and to prevent negative self-image and body image, as well as to development media literacy. In this study, the investigators will focus on the "Young In Favor of Myself " program, designed for ages 10-12, grades 5 and 6, and its main goal is the development of self-care behaviors, media literacy, positive self-esteem, and body-image. To increase the effect of "Young In Favor of Myself " program, on the adolescents, the investigators have developed a teacher component as an addition to the school-based intervention, usually delivered by college students. The study will first assess the teachers' influence on the program, and then evaluate the difference in adolescent outcomes from the program with or without this supplement.

Results will be measured using the study questionnaire, to be filled out by the participants (both teachers and adolescents) before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. The study protocol was approved by Tel Hai College institutional review board. Parents of all participants, in the intervention and in the control group, as well as teachers involved in the program, received information about the program and the study and were asked to provide informed consent.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Upper Galilee
      • Kiryat Shmona, Upper Galilee, Israele, 1220800
        • Tel Hai College

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 10 anni a 70 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Inclusion Criteria:

Teachers of elementary school classes 10-12-year-old students of participating teachers Participants who filled out the questionnaires before and after the program Participants whose parents signed a letter of informed consent.

Exclusion Criteria:

  • Participants who didn't complete the questionnaires at baseline or at least twice.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Prevention Program "young In Favor of Myself", active teachers
The program "young In Favor of Myself" will be delivered to adolescence aged 10-12, over 3 months. The program contains nine weekly, 90-min sessions that focus on Media literacy, self-esteem, self-image and body image. The teachers will also participate by delivering planned activities to do with their pupils in addition to each week's topic, parallel to the externally-delivered program. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program.
Prevention program: "young In Favor of Myself", with teacher participation
Comparatore attivo: Prevention Program "young In Favor of Myself", passive teachers
The program "young In Favor of Myself" will be delivered to adolescence aged 10-12, over 3 months. The program contains nine weekly, 90-min sessions that focus on Media literacy, self-esteem, self-image and body image. The teachers won't participate in the program, they will only be present in the classroom during the externally-delivered program. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program.
Prevention program: "young In Favor of Myself", without teacher participation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale.
Lasso di tempo: Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

The Sociocultural Attitudes Towards Appearance Questionnaire (Schaefer et al., 2015). The investigators included the Media subscale, including 4 items. Items are rated on a 5-point scale: (1) always, (2) often, (3) sometimes, (4) rarely, (5) never. The total score is based on computing the average. A higher score indicates higher pressure from the media to change one's look.

The scale will only be used in the child questionnaire, not in the teacher version.

Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores
Change from Baseline in Rosenberg Self Esteem Scale
Lasso di tempo: Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items. Scoring involves a method of combined ratings. Low self-esteem responses are "disagree" or "strongly disagree" on items 1, 3, 4, 7, 10, and "strongly agree" or "agree" on items 2, 5, 6, 8, 9. Two or three out of three correct responses to items 3, 7, and 9 are scored as one item. One or two out of two correct responses for items 4 and 5 are considered as a single item; items 1,8, and 10 are scored as individual items; and combined correct responses (one or two out of two) to items 2 and 6 are considered to be a single item.

The scale will only be used in the child questionnaire, not in the teacher version.

Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores
Change from Baseline in Body Esteem Scale
Lasso di tempo: Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores
Body Esteem Scale- This questionnaire examines self-esteem of body and physical appearance and consists of 3 subscales: appearance (10 items), weight (8 items) and attribution 187 to others (5 items). Items are rated on a 5-point scale: (1) never, (2) rarely, (3) sometimes, (4) 188 often, and (5) always. A higher score indicates higher body-esteem (Mendelson, Mendelson, & White, 2001) The scale will be used in both the child and teacher questionnaire versions.
Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores
Change from Baseline in Child- Eating Disorder Examination- Questionnaire (Ch-EDE-Q8)
Lasso di tempo: Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores
Child Eating Disorder Examination- Questionnaire short version (EDE-Q8). The items are rated on a 6-point scale: (1) never, (2) rarely, (3) sometimes, (4) often, (5) usually, and (6) always. EDE-Q provides assessment of eating disorder psychopathology related to anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). (Kliem et al, 2016) The scale will only be used in the child questionnaire, not in the teacher version.
Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores
Change from Baseline in Advertising Scale
Lasso di tempo: Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

The Advertising scale contains 1 item- Identification of strategies used by media. This question is reflected as a protective factor. It contains 8 different strategies which participants choose from: higher number of strategies identified indicate better media literacy. (Golan et al., 2013).

The scale will only be used in the child questionnaire, not in the teacher version.

Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores
Change from Baseline in Self-Care behaviors
Lasso di tempo: Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

Developed by Prof. Moria Golan and assessed in previous research. Includes 14 items which are rated on a 4-point scale: (1) never, (2) rarely, (3) sometimes, (4) always. Items are summed, and higher scores indicate higher self-care behaviors. This questionnaire was designed to assess self care behaviors in adolescents.

The scale will only be used in the child questionnaire, not in the teacher version.

Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in The Connor-Davidson Resilience Scale (CD-RISC)
Lasso di tempo: Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the course, measuring a change in scores

The CD-RISC is based on Connor and Davidson's operational definition of resilience, which is the ability to "thrive in the face of adversity." The scale includes 25 items, from 5 sub-scales:

Personal competence, high standards, and tenacity Trust in one's instincts, tolerance of negative affect, and strengthening effects of stress Positive acceptance of change and secure relationships Control Spiritual influences Scoring: Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-25, the full range is therefore from 0 to 100, with higher scores reflecting greater resilience. (Connor KM, Davidson JRT. Depression and Anxiety 2003; 18: 71-82).

The scale will only be used in the teacher questionnaire, not in the child version.

Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the course, measuring a change in scores

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2020

Completamento primario (Anticipato)

1 giugno 2022

Completamento dello studio (Anticipato)

1 ottobre 2022

Date di iscrizione allo studio

Primo inviato

15 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

18 dicembre 2020

Primo Inserito (Effettivo)

24 dicembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 agosto 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Tel-Hai-College

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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