FamilyFAMPARTNCT04957394
Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention
A study testing Family Partner in people with Family and Parenting, run by Oslo Metropolitan University at 3 sites in Norway.
Trial summary
Prior to this pilot study, it is unclear whether comparing a manualized version of the Family Partner Model to standard practice in the Child Welfare Services would be feasible. Results will inform whether and how to design a fully powered randomized controlled trial to test the effects of a manualized version of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family, Parenting, Child Maltreatment
- What is being tested?
- Family Partner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Jan 2022to 18 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- parents are 18 years or older, and
- children are under 18 years, and
- families with complex challenges who are already involved in the Child Welfare Services, and
- children live under potentially harmful circumstances, and
- parents struggle in several areas, e.g. employment, poverty, drug misuse, mental health
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Øvre Eiker kommune
Drammen
Larvik kommune
Larvik
Lillehammer kommune
Lillehammer
About this study
Official title: Family Partner -Co-development, Implementation and Evaluation of a Child Maltreatment Prevention Intervention
Prior to this pilot study, it is unclear whether comparing a manualized version of the Family Partner Model to standard practice in the Child Welfare Services would be feasible. Results will inform whether and how to design a fully powered randomized controlled trial to test the effects of a manualized version of the Family Partner Model on child maltreatment. The specific results of the pilot study will inform 1) randomization procedures, 2) data sources to be used, 3) sample size calculations, and 4) adaptations to the design and measures for a fully powered randomized controlled trial.
Read the detailed description
The objective is to assess the adaptability and acceptability of the Family Partner Intervention, and the feasibility of a future randomised controlled trial. Our specific research questions are:
- What is the adaptability, acceptability, and feasibility of the Family Partner intervention in a Norwegian municipal context?
- What are the experiences and possible outcomes of the Family Partner intervention?
- Is the trial design feasible for an RCT expansion?
The investigators will pilot a parallel randomized trial (RCT), allocated to two groups (treatment and control). Families that fit to the target group, will be invited to take part in the study. Each family which fit the inclusion criteria and consent to participate will be randomized with a 1:1 allocation to experimental and control groups. Each Family Partner can serve 5 families at a time, and the Family Partner will serve families from 6-18 months. As families complete the programme, new families will be recruited. Hence, the recruitment and randomization will be an ongoing process. Any changes to methods after pilot trial commencement will be reported along with study results.
In a future RCT, the objective is to evaluate the effectiveness of the Family Partner Intervention, i.e. whether introducing the intervention would improve the outcome of existing Child Welfare Services. Hence, the trial is a superiority trial, in which the Family Partner Intervention is hypothesized to be superior to existing service provision. The trial is designed according to an intention-to-treat principle, where all consented participants are included in the analyses, independent of their adherence to intervention.
- Conditions
- Family, Parenting, Child Maltreatment
- Being tested
- Family Partner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family PartnerBehavioural
The Family Partner intervention is based on well-known elements for preventing child abuse and neglect, such as 1) high intensity intervention with home visitations, 2) coordination of services, 3) an ecological perspective, 4) parental guidance, and 5) an emphasis on a therapeutic relationship with parents to create trust, change and agency.
Family Partners must have relevant professional background and education, such as social work, child welfare services and other health/welfare occupations. They must have a personal attitude for relation-based service delivery in a home-setting, a long work experience and in-depth knowledge of municipal welfare services.
Each practitioner will follow five families. The estimated duration of the intervention is 12 months, but might go over longer stretches of time if it is considered beneficial for the families. The minimum duration of the intervention is 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Family Partner) | Experimental | The treatment group will receive six hours follow-up and support weekly. The service will be provided by a dedicated Family Partner. Receives: Behavioral: Family Partner |
| Control group | No intervention | The control group will receive default support from the child welfare services. The service will be "business as usual", provided by the local staff at the child welfare services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Intervention Rating Profile (IRP-15)
Measured: Acceptability at 12 months
Secondary outcomes (1)
Relationship between the Family Partner and the parents
The Working Alliance Inventory (WAI)
Measured: Change from Baseline WAI at 3, 6, 9, 12, 15 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Jan 2022
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
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 FamilyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- SOS Children's Villages, Norway, Øvre Eiker municipality, Lillehammer municipality
- Responsible party
- Sponsor
- Investigators
- Anne Grete G Tøge, phd, Principal investigator, associate professorEirin G Pedersen, phd, Principal investigator, Senior Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957394
- Sponsor's protocol ID
- 804402
- Acronym
- FAMPART
- Status last verified
- Apr 2025
- First submitted
- 28 Jun 2021
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finne J, Toge AG, Wiggen KS, Ekre M, Malmberg-Heimonen I, Pontoppidan M, Dion J, Tommeras T, Pedersen E. Results from a randomized controlled pilot trial of a home-visiting intervention to reduce child maltreatment. Pilot Feasibility Stud. 2025 Jun 3;11(1):77. doi: 10.1186/s40814-025-01659-9.
PubMed 40462144Pedersen E, Malmberg-Heimonen I, Finne J, Pontoppidan M, Dion J, Tommeras T, Toge AG. Family Partner: study protocol for a pilot randomised study of a home-visitation intervention in Norway. Scand J Public Health. 2024 Aug;52(6):761-768. doi: 10.1177/14034948231189773. Epub 2023 Aug 14.
PubMed 37574994
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Partner -Co-development, Implementation and Evaluation of a Child Maltreatment Prevention Intervention
- ClinicalTrials.gov ID
- NCT04957394
- Acronym / sponsor ID
- FAMPART / 804402
- Conditions
- Family, Parenting, Child Maltreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- SOS Children's Villages, Norway, Øvre Eiker municipality, Lillehammer municipality
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 12 Jul 2021 (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.
Prior to this pilot study, it is unclear whether comparing a manualized version of the Family Partner Model to standard practice in the Child Welfare Services would be feasible. Results will inform whether and how to design a fully powered randomized controlled trial to test the effects of a manualized version of the Family Partner Model on child maltreatment. The specific results of the pilot study will inform 1) randomization procedures, 2) data sources to be used, 3) sample size calculations, and 4) adaptations to the design and measures for a fully powered randomized controlled trial.
Detailed description
The objective is to assess the adaptability and acceptability of the Family Partner Intervention, and the feasibility of a future randomised controlled trial. Our specific research questions are:
- What is the adaptability, acceptability, and feasibility of the Family Partner intervention in a Norwegian municipal context?
- What are the experiences and possible outcomes of the Family Partner intervention?
- Is the trial design feasible for an RCT expansion?
The investigators will pilot a parallel randomized trial (RCT), allocated to two groups (treatment and control). Families that fit to the target group, will be invited to take part in the study. Each family which fit the inclusion criteria and consent to participate will be randomized with a 1:1 allocation to experimental and control groups. Each Family Partner can serve 5 families at a time, and the Family Partner will serve families from 6-18 months. As families complete the programme, new families will be recruited. Hence, the recruitment and randomization will be an ongoing process. Any changes to methods after pilot trial commencement will be reported along with study results.
In a future RCT, the objective is to evaluate the effectiveness of the Family Partner Intervention, i.e. whether introducing the intervention would improve the outcome of existing Child Welfare Services. Hence, the trial is a superiority trial, in which the Family Partner Intervention is hypothesized to be superior to existing service provision. The trial is designed according to an intention-to-treat principle, where all consented participants are included in the analyses, independent of their adherence to intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Family Partner) | Experimental | Behavioral: Family PartnerThe treatment group will receive six hours follow-up and support weekly. The service will be provided by a dedicated Family Partner. |
| Control group | No intervention | –The control group will receive default support from the child welfare services. The service will be "business as usual", provided by the local staff at the child welfare services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- parents are 18 years or older, and
- children are under 18 years, and
- families with complex challenges who are already involved in the Child Welfare Services, and
- children live under potentially harmful circumstances, and
- parents struggle in several areas, e.g. employment, poverty, drug misuse, mental health
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Family PartnerThe Family Partner intervention is based on well-known elements for preventing child abuse and neglect, such as 1) high intensity intervention with home visitations, 2) coordination of services, 3) an ecological perspective, 4) parental guidance, and 5) an emphasis on a therapeutic relationship with parents to create trust, change and agency. Family Partners must have relevant professional background and education, such as social work, child welfare services and other health/welfare occupations. They must have a personal attitude for relation-based service delivery in a home-setting, a long work experience and in-depth knowledge of municipal welfare services. Each practitioner will follow five families. The estimated duration of the intervention is 12 months, but might go over longer stretches of time if it is considered beneficial for the families. The minimum duration of the intervention is 3 months. | Behavioural | Experimental (Family Partner) |
Primary outcome
Acceptability
Time frame: Acceptability at 12 months
Intervention Rating Profile (IRP-15)
1 secondary outcome
Relationship between the Family Partner and the parents
Time frame: Change from Baseline WAI at 3, 6, 9, 12, 15 and 18 months
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 11 Aug 2025.
- Derived from this study: PubMed 40462144Finne J, Toge AG, Wiggen KS, Ekre M, Malmberg-Heimonen I, Pontoppidan M, Dion J, Tommeras T, Pedersen E. Results from a randomized controlled pilot trial of a home-visiting intervention to reduce child maltreatment. Pilot Feasibility Stud. 2025 Jun 3;11(1):77. doi: 10.1186/s40814-025-01659-9.
- Derived from this study: PubMed 37574994Pedersen E, Malmberg-Heimonen I, Finne J, Pontoppidan M, Dion J, Tommeras T, Toge AG. Family Partner: study protocol for a pilot randomised study of a home-visitation intervention in Norway. Scand J Public Health. 2024 Aug;52(6):761-768. doi: 10.1177/14034948231189773. Epub 2023 Aug 14.
- Individual participant dataSharing planned: No
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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.
Anne Grete G Tøge, phd principal investigator
associate professor
Eirin G Pedersen, phd principal investigator
Senior Researcher
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Partner in people with Family and Parenting, run by Oslo Metropolitan University at 3 sites in Norway.
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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
Acceptability (time frame: Acceptability at 12 months). 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 NCT04957394, 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 11 Aug 2025.