New in Town-Internet Intervention for Migrants

Sponsor
University of Social Sciences and Humanities, Warsaw (Other)
Overall Status
Terminated
CT.gov ID
NCT04088487
Collaborator
(none)
178
1
2
3.8
47.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: New in Town-Interner Intervention for Migrants
N/A

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

Study Type:
Interventional
Actual Enrollment :
178 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
New in Town-Internet Intervention for Migrants: a Randomized Controlled Trial
Actual Study Start Date :
Jan 14, 2020
Actual Primary Completion Date :
Apr 3, 2020
Actual Study Completion Date :
May 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

Participants gain access to the internet intervention after the baseline measurement (pre-test).

Behavioral: New in Town-Interner Intervention for Migrants
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).

Other: Waitlist control group

Participants gain access to the internet intervention 8 weeks after the baseline measurement (pre-test).

Behavioral: New in Town-Interner Intervention for Migrants
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).

Outcome Measures

Primary Outcome Measures

  1. Change on Social Self-Efficacy [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.

  2. Change on Social Self-Efficacy [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.

Secondary Outcome Measures

  1. Change on Loneliness [Change from baseline on Loneliness (3 weeks)]

    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.

  2. Change on Loneliness [Change from baseline on Loneliness (8 weeks)]

    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.

  3. Change on Social support [Change from baseline on Social support (3 weeks)]

    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.

  4. Change on Social support [Change from baseline on Social support (8 weeks)]

    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.

  5. Change on Satisfaction with life [Change from baseline on Satisfaction with life (3 weeks)]

    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.

  6. Change on Satisfaction with life [Change from baseline on Satisfaction with life (8 weeks)]

    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.

Other Outcome Measures

  1. System usability [3-week post-test (only experimental group)]

    An overall impression of the intervention will be assessed by The User Experience Questionnaire (UEQ). It is a self-reported measure that contains 6 subscales: attractiveness, perspicuity, efficiency, dependability, stimulation, novelty. Participants respond to 26 items using a 7-point scale (-3 = the most negative answer, 0 = neutral, +3 = the most positive answer). User experience will only be assessed at post-test among participants allocated to the experimental group.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age of at least 18 years

  • having changed the place of residence in the last 6 months

Exclusion Criteria:
  • no access to a internet

Contacts and Locations

Locations

Site City State Country Postal Code
1 SWPS University of Social Sciences and Humanities Warsaw Warszawa Poland 03-815

Sponsors and Collaborators

  • University of Social Sciences and Humanities, Warsaw

Investigators

  • Principal Investigator: Anna Rogala, PhD, SWPS University of Social Sciences and Humanities

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Social Sciences and Humanities, Warsaw
ClinicalTrials.gov Identifier:
NCT04088487
Other Study ID Numbers:
  • WP/2018/A/10
First Posted:
Sep 12, 2019
Last Update Posted:
Nov 13, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 13, 2020