Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention (FAMPART)

Oslo Metropolitan University

Status: Completed

Conditions: Parenting; Family; Child Maltreatment

Treatments: Behavioral: Family Partner

Study type: Interventional

Funder types: Other

Identifiers

NCT04957394

804402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Experimental (Family Partner)

Experimental group

Description:

The treatment group will receive six hours follow-up and support weekly. The service will be provided by a dedicated Family Partner.

Treatment:

Behavioral: Family Partner

Control group

No Intervention group

Description:

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.