Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention

Not Applicable

Active, not recruiting

• Conditions: Parenting; Child Maltreatment; Family
• Interventions: Behavioral: Family Partner

• Registration Number: NCT04957394
• Lead Sponsor: Oslo Metropolitan University

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.

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-12
• Study Start: 2022-01-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-10-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental (Family Partner)	Family Partner	The treatment group will receive six hours follow-up and support weekly. The service will be provided by a dedicated Family Partner.

Primary Outcome Measures

Name	Time	Method
Acceptability	Acceptability at 12 months	Intervention Rating Profile (IRP-15)

Secondary Outcome Measures

Name	Time	Method
Relationship between the Family Partner and the parents	Change from Baseline WAI at 3, 6, 9, 12, 15 and 18 months	The Working Alliance Inventory (WAI)

Trial Locations

Locations (3)

Øvre Eiker kommune; 🇳🇴 Drammen, Norway

Larvik kommune; 🇳🇴 Larvik, Norway

Lillehammer kommune; 🇳🇴 Lillehammer, Norway