Evaluation of an intervention to promote the psychosocial health of children of incarcerated parents and their non-incarcerated carers
| ISRCTN | ISRCTN66122609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66122609 |
| Sponsor | Karolinska Institutet |
| Funder | Swedish Research Council for Health, Working Life and Welfare |
- Submission date
- 21/11/2025
- Registration date
- 24/11/2025
- Last edited
- 24/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Children of incarcerated parents comprise a greatly disadvantaged group with high needs that are largely overlooked by society. These children run a greater risk for a number of health-related outcomes, and own delinquency. Research suggests that these children need support that focus on their resilience. The non-incarcerated caregiver is key here, but the caregiver may also be negatively affected by a partner’s incarceration and in need of support for the own well-being and to be able to support the child. Internationally, few support interventions for these children and caregivers have been evaluated scientifically. In Sweden, current support is uncoordinated, largely unavailable, and provided by non-profit organisations. In fact, the responsible stakeholder, the Social Services, largely lacks knowledge about the children’s needs. Interventions to support child resilience in general focus on promotive factors of the child and context, where parenting is emphasised.
This project aims to assess the effects of an evidence-informed intervention for children of incarcerated parents and their non-incarcerated caregivers on psychosocial health and study the implementation process.
Who can participate?
Children aged 6-13 years who have an incarcerated parent in Sweden and their non-incarcerated caregivers.
What does the study involve?
The intervention is carried out by staff in the general social service units or by staff in civil society organisations that have a specific focus on families affected by incarceration.
Units (social service or civil society organisations) are randomised to deliver the intervention or service as usual (control). Children and carers who receive services will be included in the intervention and control group according to the randomisation of the unit into intervention or control group.
The intervention for the child-carer-dyad consists of 3 individual and separate sessions for children and carers. Sessions include psychoeducation and brief strategies for managing emotions and situations related to the incarceration.
A final, 4th session is provided for child and carer together to form a common understanding and basis for continued, joint handling of the incarceration after the intervention.
The control group is provided the standard support (TAU) by the units in the control group.
To test the effects of the intervention on psychosocial health, a variety of measurement on psychosocial health are self/adult-reported before, and after the intervention, three-months, and one-year after the intervention.
The implementation process is monitored during and after the intervention by self-reported measurements from children, carers, and professionals delivering the intervention.
What are the possible benefits and risks of participating?
The intervention is thoroughly designed to avoid risk but may inflict uncomfortable memories or emotions, which are to be handled within the intervention. Children and carers who participate may be benefited by a decreased emotional suffering and prevention of future ill health.
Where is the study run from?
Karolinska Institutet/Uppsala University, Sweden
When is the study starting and how long is it expected to run for?
Start in December 2025 and ending in December 2032 (last data collection)
Who is funding the study?
The Swedish Research Council for Health, Working Life and Wellfare
Who is the main contact?
Principal Investigator Dr. Åsa Norman, Karolinska Institutet/Uppsala University, asa.norman@ki.se, asa.norman@uu.se
Contact information
Public, Scientific, Principal investigator
Nobels väg 9
Solna
17165
Sweden
| 0000-0002-0313-3066 | |
| Phone | +46(0)739204270 |
| asa.norman@ki.se |
Public, Scientific, Principal investigator
Akademiska sjukhuset
Uppsala
751 85
Sweden
| 0000-0002-0313-3066 | |
| Phone | +46(0)739204270 |
| asa.norman@uu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized controlled study design with a parallel process evaluation |
| Secondary study design | Cluster randomised trial |
| Scientific title | A cluster randomised controlled trial evaluating the effects of a parallel intervention for children of incarcerated parents and their non-incarcerated carers on psychosocial health, compared to treatment as usual |
| Study objectives | The overall aim of the project is to evaluate a newly developed two-generation intervention for children with incarcerated parents and their non-incarcerated carers with regard to the intervention effects on psychosocial health and with regard to the implementation process. The main study hypothesis is that the intervention will have a significantly beneficial effect on primary and secondary outcomes compared to the control condition. |
| Ethics approval(s) |
Approved 29/10/2025, Swedish Ethical Review Authority (Box 2110, Uppsala, 750 02, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: 2025-05014-01 |
| Health condition(s) or problem(s) studied | Prevention of poor psychosocial health in children with incarcerated parents and their non-incarcerated carers |
| Intervention | The intervention for the child-carer-dyad consists of 3 individual and separate sessions for children and carers. Sessions include psychoeducation and brief strategies for managing emotions and situations related to the incarceration. A final, 4th session is provided for child and carer together to form a common understanding and basis for continued management of the incarceration after the intervention. The control group is provided the standard support (TAU) available at the units/organisations in the control group. The intervention is carried out by staff in the general social service units or by staff in civil society organisations that have a specific focus on families affected by incarceration. Randomisation to intervention or control group will be carried out on cluster level on a 1:1 allocation ratio. Clusters will comprise units within the social services and civil society organisations that agree to participate in the project. Children and carers who receive services will be included in the intervention and control group according to the randomisation of the unit into intervention or control group. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Child: |
| Key secondary outcome measure(s) |
Secondary outcomes and mediators measured with children and carers before the start of the intervention for each family, i.e. baseline (T0), at the end of the intervention (T1), at three-months follow up (T2), and one year after the intervention (T3). |
| Completion date | 31/12/2032 |
Eligibility
| Participant type(s) | Carer, Health professional, Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 13 Years |
| Sex | All |
| Target sample size at registration | 168 |
| Key inclusion criteria | Child: 1. Age 6-13 years old. 2. Have one or both parents (biological parent, non-biological parent/carer) in prison or jail in Sweden. 3. Have sufficient proficiency in Swedish to be able to understand the intervention material. Carer: 1. Age 18 years or older. 2. Be the carer of (e.g. parent, foster parent, or other form of close carer on a regular basis for the child) at least one child aged 6-13 years with an incarcerated parent in prison or jail in Sweden. 3. Have sufficient proficiency in Swedish to be able to understand the intervention material. Deliverer: 1. Work in one of the units included in the study. 2. If randomised to intervention group: have participated in the intervention training. |
| Key exclusion criteria | Child: 1. Be the victim of a serious crime committed by the parent, such as sexual abuse. The exclusion criterion will be closely monitored by deliverers in communication with researchers including licenced psychologists, and evaluated on an individual child basis. We have seen in interviews with children (yet unpublished) that children may be the victim of crime committed by the parent, such as witnessing violence committed towards the carer, but still be in need of support for handling the parent’s incarceration. Therefore, this exclusion criterion will be closely monitored by researchers jointly with deliverers. All participating units have routines for these circumstances that we be taken into action and ensure that children will be provided additional support related to their vicitimasation. 2. Lack sufficient proficiency in Swedish to be able to understand the intervention material. 3. Have a parent in prison or jail in in another country than Sweden. Carer: 1. Be the victim of a serious crime committed by the parent (see above child criteria, the same applies here). 2. Lack sufficient proficiency in Swedish to be able to understand the intervention material. Deliverer: 1. Not work in one of the units included in the study. 2. If randomised to intervention group: Not having participated in the intervention training. |
| Date of first enrolment | 10/12/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Solna
17165
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
21/11/2025: Trial's existence confirmed by Swedish Ethical Review Authority.