ParentingNCT04101799
Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden
A study testing For Our Children's Sake in people with Parenting and Parent-Child Relations, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parenting, Parent-Child Relations
- What is being tested?
- For Our Children's Sake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSweden
- Study dates
- 21 Sep 2019to 30 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not fulfilling inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parenting, Parent-Child Relations
- Being tested
- For Our Children's Sake, Active control
- Keywords
- Prison, Criminality, Child
- Medical subject headings
- Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For Our Children's SakeBehavioural
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 controlOther
Participating in everyday activities that may include parenting activities in the control prisons
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participating in the For our children's sake intervention, 10 group sessions, 2 hours each Receives: Behavioral: For Our Children's Sake |
| Control | Active comparator | Participating in everyday activities that may include parenting activities in the control prisons Receives: Other: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-items sub-scale Closeness in the Child Parent Relationship Scale
Parent-reported quality in relationship between parent and child on a 5-point scale ('complete agree' to 'completely disagree')
Measured: 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 outcomes (3)
Contact frequency and type between parent and child
Parent-reported frequency (weekly, monthly, less, no contact) and type (letter, telephone, visit/permission, other
Measured: 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
Parental attitude to criminality self-reported on a 5-point scale ('complete agree' to 'completely disagree')
Measured: 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
One item self-reported on an 11-point scale (0 no interest, 10 very high interest)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start21 Sep 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled trial
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Solstickan Foundation, The Sven Jerring Foundation
- Responsible party
- Principal investigator, Åsa Norman, Karolinska Institutet
- Investigators
- Åsa Norman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101799
- Sponsor's protocol ID
- 2019-04227
- Other IDs
- 2019
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2019
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Norman A, Enebrink P. Effects of a parental support intervention for parents in prison on child-parent relationship and criminal attitude-The For Our Children's Sake pragmatic controlled study. PLoS One. 2023 Mar 23;18(3):e0283177. doi: 10.1371/journal.pone.0283177. eCollection 2023.
PubMed 36952468Norman A, Enebrink P. Evaluation of the For Our Children's Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial. BMJ Open. 2020 Jun 7;10(6):e034834. doi: 10.1136/bmjopen-2019-034834.
PubMed 32513881
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04101799
- Acronym / sponsor ID
- 2019-04227
- Conditions
- Parenting, Parent-Child Relations
- Keywords
- Prison, Criminality, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Solstickan Foundation, The Sven Jerring Foundation
- Study start
- 21 Sep 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 24 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: For Our Children's SakeParticipating in the For our children's sake intervention, 10 group sessions, 2 hours each |
| Control | Active comparator | Other: Active controlParticipating in everyday activities that may include parenting activities in the control prisons |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not fulfilling inclusion criteria
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 |
|---|---|---|
| For Our Children's SakeParental 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. | Behavioural | Intervention |
| Active controlParticipating in everyday activities that may include parenting activities in the control prisons | Other | Control |
Primary outcome
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')
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Derived from this study: PubMed 36952468Norman A, Enebrink P. Effects of a parental support intervention for parents in prison on child-parent relationship and criminal attitude-The For Our Children's Sake pragmatic controlled study. PLoS One. 2023 Mar 23;18(3):e0283177. doi: 10.1371/journal.pone.0283177. eCollection 2023.
- Derived from this study: PubMed 32513881Norman A, Enebrink P. Evaluation of the For Our Children's Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial. BMJ Open. 2020 Jun 7;10(6):e034834. doi: 10.1136/bmjopen-2019-034834.
- Individual participant dataSharing planned: Yes. 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.
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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.
Åsa Norman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing For Our Children's Sake in people with Parenting and Parent-Child Relations, run by Karolinska Institutet at 1 site in Sweden.
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 5 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: finished, as of the sponsor's last update on 23 Sep 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 NCT04101799, which also lists 2 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 23 Sep 2020.