Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention

Parenting Clinical Trial

— FAMPART  

Official title:

Family Partner -Co-development, Implementation and Evaluation of a Child Maltreatment Prevention Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04957394
• Other study ID #: 804402
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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:

1. What is the adaptability, acceptability, and feasibility of the Family Partner intervention in a Norwegian municipal context?

2. What are the experiences and possible outcomes of the Family Partner intervention?

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 31, 2026
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

None

Related Conditions & MeSH terms

• Child Maltreatment
• Family
• Parenting

Intervention

Behavioral:
• Family Partner
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.

Locations

Country	Name	City	State
Norway	Øvre Eiker kommune	Drammen
Norway	Larvik kommune	Larvik
Norway	Lillehammer kommune	Lillehammer

Sponsors (4)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Lillehammer municipality, Øvre Eiker municipality, SOS Children's Villages, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Intervention Rating Profile (IRP-15)	Acceptability at 12 months
Secondary	Relationship between the Family Partner and the parents	The Working Alliance Inventory (WAI)	Change from Baseline WAI at 3, 6, 9, 12, 15 and 18 months