Clinical trial NCT04957394: Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention
Official title: Family Partner -Co-development, Implementation and Evaluation of a Child Maltreatment Prevention Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Family
Parenting
Child Maltreatment
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: SOS Children's Villages, Norway
name: Øvre Eiker municipality
name: Lillehammer municipality
First posted: 2021-07-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: Acceptability at 12 months
Secondary outcomes:
measure: Relationship between the Family Partner and the parents
timeFrame: Change from Baseline WAI at 3, 6, 9, 12, 15 and 18 months
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Øvre Eiker kommune
city: Larvik
country: Norway
facility: Larvik kommune
city: Lillehammer
country: Norway
facility: Lillehammer kommune
Study officials:
affiliation: associate professor
name: Anne Grete G Tøge, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Researcher
name: Eirin G Pedersen, phd
role: PRINCIPAL_INVESTIGATOR
References: