NCT05336097

Brief Summary

The general purpose of this feasibility study is to evaluate the potential impact of Pathways to Empowerment (PTE) on the four constitutional conditions of social quality for persons living in persistent poverty. PTE is a strengths-based methodology developed for social care professionals to support persons in vulnerable positions with their recovery. PTE was chosen for evaluation based on in-depth interviews about appropriate support, a literature search, and participatory action research in which the wishes of each participating municipality were explored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

April 5, 2022

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in score on Perceived Stress Scale (PSS)

    The PSS is a 10-item instrument that measures frequency of thoughts and feelings related to perceived stress. Answers are expressed on a scale ranging from (0) "never" to (4) "very often". The PSS has been validated and widely used in the general population.

    Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)

Secondary Outcomes (6)

  • Change in score on Mental Health Inventory 5 (MHI-5)

    Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)

  • Change in score on Pearlin Mastery Scale (PMS)

    Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)

  • Change in sense of societal belonging

    Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)

  • Change in score on Multidimensional Scale of Perceived Social Support (MSPSS)

    Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)

  • Change in social participation

    Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)

  • +1 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants will receive support from participation coaches trained in Pathways to Empowerment (PTE). These participation coaches received a four-day training program with two weeks in between each training day, allowing them to immediately implement their acquired set of knowledge and skills. At the end of the training program, participation coaches had to successfully pass an end assignment to become PTE-certified. In order to ensure the implementation of PTE, the training will be supplemented with a learning cycle. This cycle consists of two workshops on poverty and stress, and of on-the-job coaching. The coaching is tailored to the wishes and needs of the team.

Other: Pathways to Empowerment

Interventions

Pathways to Empowerment (PTE) is a program for person-centered intervention. PTE is rooted in the Strengths Model by Rapp and Goscha (2011), and in the Social Quality Approach as described by Van der Maesen and Walker (2005). The general aim of PTE is to improve the quality of the daily lives of persons who experience loss of control in their lives by focusing on their strengths and stimulating their personal agency, participation in society, and self-direction in life. The main task of professionals is to help create the conditions in which growth and recovery are likely to occur.

Also known as: Krachtwerk
Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants are 18 years of age or older;
  • Participants started a support trajectory at one of the participating teams during the recruitment period;
  • Participants are living in persistent poverty. This means that participants have been having insufficient means for minimum living expenses and social participation for at least three years.

You may not qualify if:

  • Being unable to provide reliable answers (e.g., having a psychotic episode);
  • No informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Study Officials

  • Judith Wolf, PhD

    Impuls - Netherlands Center for Social Care Research, Radboudumc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 20, 2022

Study Start

April 4, 2022

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

This study examines vulnerable individuals living in persistent poverty. As the IPD contain sensitive information and publishing these data may deter potential participants, IPD will not be shared with other researchers.

Locations