Self EfficacyNCT04088487
New in Town-Internet Intervention for Migrants
A study testing New in Town-Interner Intervention for Migrants in people with Self Efficacy and Loneliness, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
Trial summary
New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. The study aim is to evaluate its effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Efficacy, Loneliness, Social Skills
- What is being tested?
- New in Town-Interner Intervention for Migrants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 sitePoland
- Study dates
- 14 Jan 2020to 8 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of at least 18 years
- having changed the place of residence in the last 6 months
Who cannot join
- no access to a internet
Trial locations and contacts
1 site in 1 country.
Poland1 site
SWPS University of Social Sciences and Humanities
Warsaw, Warszawa, 03-815
About this study
Official title: New in Town-Internet Intervention for Migrants: a Randomized Controlled Trial
New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. The study aim is to evaluate its effectiveness.
Read the detailed description
The number of migrants worldwide is growing rapidly over the past years. Migration often requires creating a whole new social network. There is something that can help migrants to do it-their beliefs. Social self-efficacy is confidence in ability to engage in social interactional tasks necessary to initiate and maintain interpersonal relationships. These beliefs are positively related to social adjustment and negatively related to acculturative stress, depression, and loneliness. Therefore, social self-efficacy may be potentially beneficial for the psychological adjustment of migrants helping them establish new connections in the social environment. Based on this observation the investigators have created New in Town, an internet intervention. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states.
The effectiveness of New in Town intervention will be tested in a two-arm randomized controlled trial with waitlist control group. Primary outcome is social self-efficacy, and secondary outcomes include loneliness, perceived social support, and satisfaction with life. Other measure of interest is system usability. Participants will be assessed at pre-test (T1), 3-week post-tests (T2), as well as 8-week follow-up (T3). The investigators aim to analyze the effect size of the intervention and between-groups comparisons at post-test and follow-up.
This study will provide insights into the effectiveness of an internet intervention in increasing social self-efficacy, perceived social support and satisfaction with life, and reducing loneliness.
- Conditions
- Self Efficacy, Loneliness, Social Skills
- Being tested
- New in Town-Interner Intervention for Migrants
- Medical subject headings
- Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New in Town-Interner Intervention for MigrantsBehavioural
New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states (Bandura, 1997).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants gain access to the internet intervention after the baseline measurement (pre-test). Receives: Behavioral: New in Town-Interner Intervention for Migrants |
| Waitlist control group | Other | Participants gain access to the internet intervention 8 weeks after the baseline measurement (pre-test). Receives: Behavioral: New in Town-Interner Intervention for Migrants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Social Self-Efficacy
Social self-efficacy will be measured with the General Self-efficacy Scale (GSES). The measure consists of two subscales for measuring 1) generalized beliefs about self-efficacy (17 test items) and 2) beliefs about self-efficacy in establishing and maintaining relationships with others (6 test items). The remaining test items (7) are buffer theorems. The respondents give answers on a scale 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). In the trial, the investigators will use one subscale, which is beliefs about self-efficacy in establishing and maintaining relationships with others. Social self-efficacy will be indicated by the total sum of 6 items scores. The higher total score represents higher social self-efficacy.
Measured: Change from baseline on Social Self-Efficacy (3 weeks)
Change on Social Self-Efficacy
Social self-efficacy will be measured with the General Self-efficacy Scale (GSES). The measure consists of two subscales for measuring 1) generalized beliefs about self-efficacy (17 test items) and 2) beliefs about self-efficacy in establishing and maintaining relationships with others (6 test items). The remaining test items (7) are buffer theorems. The respondents give answers on a scale 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). In the trial, the investigators will use one subscale, which is beliefs about self-efficacy in establishing and maintaining relationships with others. Social self-efficacy will be indicated by the total sum of 6 items scores. The higher total score represents higher social self-efficacy.
Measured: Change from baseline on Social Self-Efficacy (8 weeks)
Secondary outcomes (6)
Change on Loneliness
To measure loneliness, the investigators will use De Jong Gierveld Loneliness Scale. The scale is composed of 11 items; 6 of them are formulated negatively and 5 positively. Each item is measured using on 5-point Likert scale (1 = definitely yes, 5 = definitely no). Positive items should be reversed. The sum of scores is counted on 2 separate subscales: emotional and social loneliness. The higher total score represents higher loneliness.
Measured: Change from baseline on Loneliness (3 weeks)
Change on Loneliness
To measure loneliness, the investigators will use De Jong Gierveld Loneliness Scale. The scale is composed of 11 items; 6 of them are formulated negatively and 5 positively. Each item is measured using on 5-point Likert scale (1 = definitely yes, 5 = definitely no). Positive items should be reversed. The sum of scores is counted on 2 separate subscales: emotional and social loneliness. The higher total score represents higher loneliness.
Measured: Change from baseline on Loneliness (8 weeks)
Change on Social support
To measure social support, the investigators will use The Berlin Social Support Scale (BSSS). The scale consists of 6 subscales: perceived available support, need for support, support seeking, actually received support (recipient), provided support (provider), protective buffering scale. The BSSS contains 32 items that are scored on a 4-point scale (1 = strongly disagree, 4 = strongly agree). Before scoring items negative ones need to be reversed. Scores will be counted both on a general scale and subscales. In the trial, only 3 of 6 subscales will be applied: perceived available support (8 test items), need for support (4 test items), and support seeking (5 test items). The higher total score represents higher social support.
Measured: Change from baseline on Social support (3 weeks)
Change on Social support
To measure social support, the investigators will use The Berlin Social Support Scale (BSSS). The scale consists of 6 subscales: perceived available support, need for support, support seeking, actually received support (recipient), provided support (provider), protective buffering scale. The BSSS contains 32 items that are scored on a 4-point scale (1 = strongly disagree, 4 = strongly agree). Before scoring items negative ones need to be reversed. Scores will be counted both on a general scale and subscales. In the trial, only 3 of 6 subscales will be applied: perceived available support (8 test items), need for support (4 test items), and support seeking (5 test items). The higher total score represents higher social support.
Measured: Change from baseline on Social support (8 weeks)
Change on Satisfaction with life
To measure satisfaction with life, the investigators will use The Satisfaction with Life Scale (SWLS). It is a short scale to assess perceived satisfaction with one's life. It consists of 5 items. The respondents provide answers on a 7-point scale (1 = strongly disagree, 7 = strongly agree). Possible scores range from 5 to 35, while score of 20 indicates a neutral point. The higher total score represents higher satisfaction with life.
Measured: Change from baseline on Satisfaction with life (3 weeks)
Change on Satisfaction with life
To measure satisfaction with life, the investigators will use The Satisfaction with Life Scale (SWLS). It is a short scale to assess perceived satisfaction with one's life. It consists of 5 items. The respondents provide answers on a 7-point scale (1 = strongly disagree, 7 = strongly agree). Possible scores range from 5 to 35, while score of 20 indicates a neutral point. The higher total score represents higher satisfaction with life.
Measured: Change from baseline on Satisfaction with life (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start14 Jan 2020
- Primary completion3 Apr 2020
- Study completion8 May 2020
Why it stopped: Intervention includes tasks that encourage participants to interact with the social environment which is unethical due to the outbreak of COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Self EfficacyStudies 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Rogala, PhD, Principal investigator, SWPS University of Social Sciences and Humanities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088487
- Sponsor's protocol ID
- WP/2018/A/10
- Status last verified
- Nov 2020
- First submitted
- 6 Aug 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bandura, A. (1997). Self-efficacy: The exercise of control. Macmillan.
Connolly, J. (1989). Social self-efficacy in adolescence: Relations with self-concept, social adjustment, and mental health. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement, 21(3), 258.
Constantine MG, Okazaki S, Utsey SO. Self-concealment, social self-efficacy, acculturative stress, and depression in African, Asian, and Latin American international college students. Am J Orthopsychiatry. 2004 Jul;74(3):230-241. doi: 10.1037/0002-9432.74.3.230.
PubMed 15291700Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Gierveld, J. D. J., & Van Tilburg, T. (1999). Manual of the loneliness scale. Amsterdam: Department of Social Research Methodology.
Łuszczyńska, A., Mazurkiewicz, M., Kowalska, M., & Schwarzer, R. (2006). Berlińskie skale wsparcia społecznego (BSSS): Wyniki wstępnych badań nad adaptacją skal i ich własnośnciami psychometrycznymi = Berlin social support scales (BSSS): Polish version of BSSS and preliminary results on its psychometric properties. Studia Psychologiczne, 44(3), 17-27.
Sherer, M., Maddux, J. E., Mercandante, B., Prentice-Dunn, S., Jacobs, B., & Rogers, R. W. (1982). The self-efficacy scale: Construction and validation. Psychological reports, 51(2), 663-671.
Smith, H. M., & Betz, N. E. (2000). Development and validation of a scale of perceived social self-efficacy. Journal of Career Assessment, 8(3), 283-301.
Schrepp, M., Pérez Cota, M., Gonçalves, R., Hinderks, A., & Thomaschewski, J. (2017). Adaption of user experience questionnaires for different user groups. Universal Access in the Information Society, 16(3), 629-640.
United Nations (2017). 2017 International Migration Report.
Maj A, Matynia M, Michalak N, Bis A, Andersson G. New in Town-An internet-based self-efficacy intervention for internal migrants: A randomized controlled trial. PLoS One. 2024 Mar 7;19(3):e0299638. doi: 10.1371/journal.pone.0299638. eCollection 2024.
PubMed 38452136Rogala A, Szczepaniak M, Michalak N, Andersson G. Internet-based self-help intervention aimed at increasing social self-efficacy among internal migrants in Poland: Study protocol for a randomized controlled trial. Internet Interv. 2020 Apr 23;21:100322. doi: 10.1016/j.invent.2020.100322. eCollection 2020 Sep.
PubMed 32328440
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New in Town-Internet Intervention for Migrants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04088487
- Acronym / sponsor ID
- WP/2018/A/10
- Conditions
- Self Efficacy, Loneliness, Social Skills
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intervention includes tasks that encourage participants to interact with the social environment which is unethical due to the outbreak of COVID-19.
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- 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.
New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. The study aim is to evaluate its effectiveness.
Detailed description
The number of migrants worldwide is growing rapidly over the past years. Migration often requires creating a whole new social network. There is something that can help migrants to do it-their beliefs. Social self-efficacy is confidence in ability to engage in social interactional tasks necessary to initiate and maintain interpersonal relationships. These beliefs are positively related to social adjustment and negatively related to acculturative stress, depression, and loneliness. Therefore, social self-efficacy may be potentially beneficial for the psychological adjustment of migrants helping them establish new connections in the social environment. Based on this observation the investigators have created New in Town, an internet intervention. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states.
The effectiveness of New in Town intervention will be tested in a two-arm randomized controlled trial with waitlist control group. Primary outcome is social self-efficacy, and secondary outcomes include loneliness, perceived social support, and satisfaction with life. Other measure of interest is system usability. Participants will be assessed at pre-test (T1), 3-week post-tests (T2), as well as 8-week follow-up (T3). The investigators aim to analyze the effect size of the intervention and between-groups comparisons at post-test and follow-up.
This study will provide insights into the effectiveness of an internet intervention in increasing social self-efficacy, perceived social support and satisfaction with life, and reducing loneliness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: New in Town-Interner Intervention for MigrantsParticipants gain access to the internet intervention after the baseline measurement (pre-test). |
| Waitlist control group | Other | Behavioral: New in Town-Interner Intervention for MigrantsParticipants gain access to the internet intervention 8 weeks after the baseline measurement (pre-test). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age of at least 18 years
- having changed the place of residence in the last 6 months
Key exclusion criteria (1 listed)
- no access to a internet
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 |
|---|---|---|
| New in Town-Interner Intervention for MigrantsNew in Town is an internet intervention for migrants that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states (Bandura, 1997). | Behavioural | Experimental group, Waitlist control group |
Primary outcome
Change on Social Self-Efficacy
Time frame: Change from baseline on Social Self-Efficacy (3 weeks)
Social self-efficacy will be measured with the General Self-efficacy Scale (GSES). The measure consists of two subscales for measuring 1) generalized beliefs about self-efficacy (17 test items) and 2) beliefs about self-efficacy in establishing and maintaining relationships with others (6 test items). The remaining test items (7) are buffer theorems. The respondents give answers on a scale 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). In the trial, the investigators will use one subscale, which is beliefs about self-efficacy in establishing and maintaining relationships with others. Social self-efficacy will be indicated by the total sum of 6 items scores. The higher total score represents higher social self-efficacy.
Change on Social Self-Efficacy
Time frame: Change from baseline on Social Self-Efficacy (8 weeks)
Social self-efficacy will be measured with the General Self-efficacy Scale (GSES). The measure consists of two subscales for measuring 1) generalized beliefs about self-efficacy (17 test items) and 2) beliefs about self-efficacy in establishing and maintaining relationships with others (6 test items). The remaining test items (7) are buffer theorems. The respondents give answers on a scale 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). In the trial, the investigators will use one subscale, which is beliefs about self-efficacy in establishing and maintaining relationships with others. Social self-efficacy will be indicated by the total sum of 6 items scores. The higher total score represents higher social self-efficacy.
6 secondary outcomes
Change on Loneliness
Time frame: Change from baseline on Loneliness (3 weeks)
Change on Loneliness
Time frame: Change from baseline on Loneliness (8 weeks)
Change on Social support
Time frame: Change from baseline on Social support (3 weeks)
Change on Social support
Time frame: Change from baseline on Social support (8 weeks)
Change on Satisfaction with life
Time frame: Change from baseline on Satisfaction with life (3 weeks)
Change on Satisfaction with life
Time frame: Change from baseline on Satisfaction with life (8 weeks)
Results and safety
The study was stopped early (reason given: Intervention includes tasks that encourage participants to interact with the social environment which is unethical due to the outbreak of COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- BackgroundBandura, A. (1997). Self-efficacy: The exercise of control. Macmillan.
- BackgroundConnolly, J. (1989). Social self-efficacy in adolescence: Relations with self-concept, social adjustment, and mental health. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement, 21(3), 258.
- Background: PubMed 15291700Constantine MG, Okazaki S, Utsey SO. Self-concealment, social self-efficacy, acculturative stress, and depression in African, Asian, and Latin American international college students. Am J Orthopsychiatry. 2004 Jul;74(3):230-241. doi: 10.1037/0002-9432.74.3.230.
- Background: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- BackgroundGierveld, J. D. J., & Van Tilburg, T. (1999). Manual of the loneliness scale. Amsterdam: Department of Social Research Methodology.
- BackgroundŁuszczyńska, A., Mazurkiewicz, M., Kowalska, M., & Schwarzer, R. (2006). Berlińskie skale wsparcia społecznego (BSSS): Wyniki wstępnych badań nad adaptacją skal i ich własnośnciami psychometrycznymi = Berlin social support scales (BSSS): Polish version of BSSS and preliminary results on its psychometric properties. Studia Psychologiczne, 44(3), 17-27.
- BackgroundSherer, M., Maddux, J. E., Mercandante, B., Prentice-Dunn, S., Jacobs, B., & Rogers, R. W. (1982). The self-efficacy scale: Construction and validation. Psychological reports, 51(2), 663-671.
- BackgroundSmith, H. M., & Betz, N. E. (2000). Development and validation of a scale of perceived social self-efficacy. Journal of Career Assessment, 8(3), 283-301.
- BackgroundSchrepp, M., Pérez Cota, M., Gonçalves, R., Hinderks, A., & Thomaschewski, J. (2017). Adaption of user experience questionnaires for different user groups. Universal Access in the Information Society, 16(3), 629-640.
- BackgroundUnited Nations (2017). 2017 International Migration Report.
- Derived from this study: PubMed 38452136Maj A, Matynia M, Michalak N, Bis A, Andersson G. New in Town-An internet-based self-efficacy intervention for internal migrants: A randomized controlled trial. PLoS One. 2024 Mar 7;19(3):e0299638. doi: 10.1371/journal.pone.0299638. eCollection 2024.
- Derived from this study: PubMed 32328440Rogala A, Szczepaniak M, Michalak N, Andersson G. Internet-based self-help intervention aimed at increasing social self-efficacy among internal migrants in Poland: Study protocol for a randomized controlled trial. Internet Interv. 2020 Apr 23;21:100322. doi: 10.1016/j.invent.2020.100322. eCollection 2020 Sep.
- Individual participant dataSharing planned: No
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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.
Anna Rogala, PhD principal investigator
SWPS University of Social Sciences and Humanities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New in Town-Interner Intervention for Migrants in people with Self Efficacy and Loneliness, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
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 2 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: stopped early, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Intervention includes tasks that encourage participants to interact with the social environment which is unethical due to the outbreak of COVID-19.). Results are not available in the source record.
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?
Change on Social Self-Efficacy (time frame: Change from baseline on Social Self-Efficacy (3 weeks)). 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 NCT04088487, which also lists 12 linked publications.
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 13 Nov 2020.