Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden

September 22, 2020 updated by: Åsa Norman, Karolinska Institutet

Children of Incarcerated Parents - Evaluation of Parental Support Programme in Prison to Promote Positive Parenting and Prevent Children's Ill-health and Delinquency Later in Life

Evaluation of the effects of the parental support intervention "For our children's sake" on positive parenting outcomes when conducted with incarcerated parents in prisons in Sweden.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Children of incarcerated parents comprise a greatly disadvantaged group in society with elevated risk of ill-health, behavioural problems, and own delinquency and unemployment later in life. Positive parenting comprise an important factor for children's positive and healthy development. Incarcerated parents may have difficulties to engage in positive parenting due to disadvantaged situations affecting parenting negatively such as drug addiction, poverty, or lack of experience of positive parenting in their own childhood. Previous research has suggested that interventions to prevent the intergenerational effect of criminality should be targeting family factors where positive parenting has been emphasised. Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes such as positive parent-child interaction, parenting knowledge, empathy, parent stress, increased child contact and active parenting, However, the majority of the programmes evaluated to date have been conducted in the US, with a prison and probation context with limited generalisability to the Swedish system. In Sweden, the parenting programme for incarcerated parents, "For our children's' sake" (FOCS) was developed in 2012-2014 with the aim to support positive parenting for the child's healthy development and is currently delivered in Swedish prisons. The aim of this project is to evaluate the effects of the FOCS parenting programme on parenting outcomes through a controlled trial with a parallel implementation process evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Serving a sentence at any of the included prisons
  • Having at least one child in the ages between 0-18 years. Parents of children aged 0-2 and 13-18 years will not be included in the primary outcome measure, as the measure is not developed for these age groups. These parents will be included in the mediator measurements.
  • Are in contact with their child/children in any form. If not, these parents are included in the mediator measurements, as the primary outcome: relationship quality, is not applicable.
  • Having the legal right to contact the child
  • Not committed either a crime against the child or any violent crime against the other parent

Exclusion Criteria:

  • Not fulfilling inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
Participating in the For our children's sake intervention, 10 group sessions, 2 hours each
Behavioral: For Our Children's Sake
Parental support with the aim to support positive parenting and promote healthy child development. Conducted in group-format with weekly 2.hour sessions conducted by trained group leaders according to a programme manual.
ACTIVE_COMPARATOR: Control
Participating in everyday activities that may include parenting activities in the control prisons
Other: Active control
Participating in everyday activities that may include parenting activities in the control prisons

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
7-items sub-scale Closeness in the Child Parent Relationship Scale
Time Frame: Positive change in mean score of all 7 items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.
Parent-reported quality in relationship between parent and child on a 5-point scale ('complete agree' to 'completely disagree')
Positive change in mean score of all 7 items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contact frequency and type between parent and child
Time Frame: Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.
Parent-reported frequency (weekly, monthly, less, no contact) and type (letter, telephone, visit/permission, other
Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.
Eight items chosen from the sub-scale antisocial intent in the Measures of Criminal Attitudes and Associates scale
Time Frame: Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.
Parental attitude to criminality self-reported on a 5-point scale ('complete agree' to 'completely disagree')
Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.
Parent interest in other treatment programmes in prison
Time Frame: Change in item score between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.
One item self-reported on an 11-point scale (0 no interest, 10 very high interest)
Change in item score between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
14 item parenting attitude from the The Adult-Adolescent Parenting Inventory (AAPI-2)
Time Frame: Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.
Intermediate outcome/mediator self-reported on a 5-point scale ('complete agree' to 'completely disagree')
Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.
6 items parental self-efficacy scale
Time Frame: Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.
Intermediate outcome/mediator self-reported on a 5-point scale ('complete agree' to 'completely disagree')
Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Solstickan Foundation, The Sven Jerring Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Åsa Norman, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-04227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data cannot be shared publicly because of ethical reasons, where public availability would compromise participant privacy. Data are available from the Department of Clinical Neuroscience, Karolinska Institute (contact via registrator@cns.ki.se) for researchers who meet the criteria for access to confidential data.

IPD Sharing Time Frame

After article publication

IPD Sharing Access Criteria

Data cannot be shared publicly because of ethical reasons, where public availability would compromise participant privacy. Data are available from the Department of Clinical Neuroscience, Karolinska Institute (contact via registrator@cns.ki.se) for researchers who meet the criteria for access to confidential data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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