CompletedNot Applicable

A Randomized Controlled Study of Safer Kids: A Manualized Intervention to Prevent Child Abuse

Sweden112 participantsStarted 2019-11-15

Plain-language summary

One of the most important responsibilities for the social services is to investigate suspected child abuse and to offer suitable intervention for the families. The lack of published studies on the effect of such interventions is therefore noteworthy. Globally, few controlled studies have been published and none of them have been conducted in Sweden. To better guide the social services in the selection of interventions, the need for Swedish studies with experimental design is therefore apparent. Previous experience in using manualized interventions with families within the social services points to the importance of regarding issues of implementation and dissemination. Interventions need to be developed and adjusted to optimize the chance of engaging families that often live under strong social pressure. The interventions also need to be designed to enable implementation and sustainability in regular services. Safer Kids is a manualized intervention offered to caregivers under investigation for child abuse. The intervention was developed by the City of Stockholm in cooperation with practitioners within the social services. The content is based on the established parenting program Comet, but has been adjusted to suit the target group. Safer Kids has already been offered for a couple of years within the social services, but has not yet been evaluated. In this project, a study of intervention effects will be conducted. Caregivers will be randomized to either receive Intervention as usual (IAU), or IAU plus Safer Kids. Effects on established risk-factors for child abuse, as well as the abused childrens' experiences, will be measures. Information on additional reports to the social services on child abuse will be collected, up to 30 month after the intervention.

Who can participate

Age range

2 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. At least one adult in the family is suspected to have perpetrated an abusive act towards a child, resulting in an initiated child welfare investigation.
. The suspected adult lives with the child, at least part time, during the investigation
. At least one child in the family is between 2-12 years old.
. The events preceding the report does not concern the child between 2-12 years old, only a younger or older sibling
. The participating caregivers have participated in an intervention concerning abuse of children at the social services in the past 12 months
. Caregiver and focus child lack residence permit the coming 30 months
. The family's problem are assessed to be so severe that there is great risk of out-of-home placement of the child during the investigation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Brief Child Abuse Potential Inventory (B-CAP)

Timeframe: Pre (0 month), Post (4 month), Follow-up (7 month), long-term follow-up (18 and 30 month)

Change in Journal records: further reports on abuse or violence

Timeframe: 4-months, 7-months, 18-months and 30-months from baseline.

Trial details

NCT IDNCT04163367

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Child Abuse trials