- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04101799
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
91
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Participating in the For our children's sake intervention, 10 group sessions, 2 hours each
|
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
|
Participating in everyday activities that may include parenting activities in the control prisons
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Collaborators
Investigators
- 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.
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)
September 21, 2019
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ACTUAL)
June 30, 2020
Study Registration Dates
First Submitted
September 20, 2019
First Submitted That Met QC Criteria
September 23, 2019
First Posted (ACTUAL)
September 24, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 23, 2020
Last Update Submitted That Met QC Criteria
September 22, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID 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.
Clinical Trials on Parent-Child Relations
-
Esteban Gómez MuzzioNot yet recruitingParent-Child Relations | Parenting | Parent-child Problem
-
The University of Hong KongCompletedParent-Child Relations | Child DevelopmentHong Kong
-
Government College University FaisalabadActive, not recruitingParent-Child RelationsPakistan
-
University of OttawaWithdrawnParent-Child RelationsCanada
-
National Taipei University of Nursing and Health...CompletedParent-Child Relations
-
University of LiegeActive, not recruitingParent-Child Relations | Child DevelopmentBelgium
-
McGill UniversitySave the Children; European Network of Foundations Children and Violence Evaluation... and other collaboratorsUnknown
-
University of CalgaryRecruitingParent-Child RelationsCanada
-
University of OttawaRecruitingParent-Child RelationsCanada
-
Universitätsklinikum Hamburg-EppendorfRecruitingParent-Child RelationsGermany
Clinical Trials on For Our Children's Sake
-
Children's Hospital Los AngelesCompletedParenting | Health Behavior | Social Acceptance
-
International Children's Palliative Care NetworkUNICEFCompletedCardiovascular Disease | Cancer | HIV | Congenital AnomaliesUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH)Completed
-
Vidya RamanCompleted
-
Shanghai Jiao Tong University School of MedicineCompletedEducational Problems | Serious Game | Augmented RealityChina
-
University of AarhusRanders Municipality, Denmark; Aarhus KommuneCompleted
-
Hospices Civils de LyonUnknown
-
Shaheed Zulfiqar Ali Bhutto Medical UniversityNot yet recruiting
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH) and other collaboratorsCompleted
-
University of FloridaCompleted