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

NCT04163367 | Completed

• 1 other identifier: Tryggare barn RCT
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Child Abuse; Child Maltreatment

Keywords

Parenting; Randomized controlled trial; Parent-Child relations; Social services; Prevention

Outcome Measures

Primary Outcomes (2)

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

  A short version of the well established CAP, which measures empirically established risk-factors for child abuse. The short version includes 24 items.

  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

  On four occasions, personnel at the included social services units will extract information from the participating families journal records. The data that will be collected by the research team is: number of additional reports to the social services concerning the family, the date of each report, as well as the reason for each report.

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

Secondary Outcomes (11)

• Change in Parent Anger Scale (PAS)

  Pre (0 month), Post (4 month) and Follow-up (7 month)

• Change in Perceived stress scale (PSS)

  Pre (0 month), Post (4 month) and Follow-up (7 month)

• Change in Patient Health Questionnaire (PHQ-9)

  Pre (0 month), Post (4 month) and Follow-up (7 month)

• Change in The Strength and Difficulties Questionnaire (SDQ)

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

• Change in Kindl-R

  Pre (0 month), Post (4 month) and Follow-up (7 month)

Other Outcomes (2)

• Safer Kids Manual Adherence Rating Scale

  After completion of Safer Kids

• Therapist Background Survey

  After starting or completing treatment with first study family

Study Arms (2)

Intervention as usual

ACTIVE COMPARATOR

The social services standard process for families reported for violence or abuse towards children. The standard process always includes a formal investigation of the suspected violence/abuse. The investigation may or may not result in voluntary or mandatory interventions, such as family support or parent training.

Other: Intervention as usual (IAU)

Intervention as usual + Safer Kids

EXPERIMENTAL

The procedure in this arm is exactly the same as in the active comparator arm (i.e., investigation that may be followed by interventions). In addition, the general parent training program Safer Kids is offered during the investigation to all participants in this arm.

Behavioral: Safer Kids; Other: Intervention as usual (IAU)

Interventions

Safer Kids BEHAVIORAL

A behaviorally based parent training program with the purpose to reduce or prevent child abuse.

Intervention as usual + Safer Kids

Intervention as usual (IAU) OTHER

Everything that's included in the social service units' regular handling of cases; such as the formal investigation and family treatment. The units cannot offer Safer Kids as a part of IAU.

Intervention as usual; Intervention as usual + Safer Kids

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• At least one adult residing in the family is suspected to have perpetrated an abusive act towards a child.
• The social services has decided to start a formal investigation of the suspected act.
• At least one child in the family is between 3 and 12 years old.

You may not qualify if:

• The social services already has an ongoing intervention with the family at the time when the suspected act is reported.
• REVISED CRITERIA (n = 101 included according to):
• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (30)

Alingsås kommun

Alingsås, Alingsås, 44181, Sweden

Location

Bjuvs kommun

Bjuv, Bjuv, 267 25, Sweden

Location

Danderyds kommun

Djursholm, Djursholm, 182 05, Sweden

Location

Fagersta kommun

Fagersta, Fagersta, 737 80, Sweden

Location

Gislaveds kommun

Gislaved, Gislaved, 332 36, Sweden

Location

Gävle kommun

Gävle, Gävle, 801 84, Sweden

Location

Hudiksvalls kommun

Hudiksvall, Hudiksvall, 824 80, Sweden

Location

Hörby kommun

Hörby, Hörby, 242 80, Sweden

Location

Höörs kommun

Höör, Höör, 243 31, Sweden

Location

Katrineholms kommun

Katrineholm, Katrineholm, 641 80, Sweden

Location

Lerums kommun

Lerum, Lerum, 443 80, Sweden

Location

Luleå kommun

Luleå, Luleå, 971 85, Sweden

Location

Mönsterås kommun

Mönsterås, Mönsterås, 383 22, Sweden

Location

Skara kommun

Skara, Skara, 532 88, Sweden

Location

Skellefteå kommun

Skellefteå, Skellefteå, 931 85, Sweden

Location

Staffanstorps kommun

Staffanstorp, Staffanstorp, 245 80, Sweden

Location

Stenungsunds kommun

Stenungsund, Stenungsund, 444 82, Sweden

Location

Sundbybergs stad

Sundbyberg, Sundbyberg, 172 92, Sweden

Location

Sundsvalls kommun

Sundsvall, Sundsvall, 851 85, Sweden

Location

Söderhamns kommun

Söderhamn, Söderhamn, 826 80, Sweden

Location

Södertälje kommun

Södertälje, Södertälje, 151 89, Sweden

Location

Tidaholms kommun

Tidaholm, Tidaholm, 522 83, Sweden

Location

Botkyrka kommun

Tumba, Tumba, 147 85, Sweden

Location

Täby kommun

Täby, Täby, 183 80, Sweden

Location

Uppsala kommun

Uppsala, Uppsala County, 753 75, Sweden

Location

Vellinge kommun

Vellinge, Vellinge, 235 81, Sweden

Location

Lidingö kommun

Lidingö, Sweden

Location

Ronneby kommun

Ronneby, Sweden

Location

Österåkers kommun

Åkersberga, Åkersberga, 184 86, Sweden

Location

Örebro kommun

Örebro, Örebro County, 70135, Sweden

Location

Related Publications (11)

• Annerback EM, Wingren G, Svedin CG, Gustafsson PA. Prevalence and characteristics of child physical abuse in Sweden - findings from a population-based youth survey. Acta Paediatr. 2010 Aug;99(8):1229-36. doi: 10.1111/j.1651-2227.2010.01792.x. Epub 2010 Mar 8.

  PMID: 20219025 BACKGROUND

• Stoltenborgh M, Bakermans-Kranenburg MJ, van Ijzendoorn MH, Alink LR. Cultural-geographical differences in the occurrence of child physical abuse? A meta-analysis of global prevalence. Int J Psychol. 2013;48(2):81-94. doi: 10.1080/00207594.2012.697165.

  PMID: 23597008 BACKGROUND

• Norman RE, Byambaa M, De R, Butchart A, Scott J, Vos T. The long-term health consequences of child physical abuse, emotional abuse, and neglect: a systematic review and meta-analysis. PLoS Med. 2012;9(11):e1001349. doi: 10.1371/journal.pmed.1001349. Epub 2012 Nov 27.

  PMID: 23209385 BACKGROUND

• Euser S, Alink LR, Stoltenborgh M, Bakermans-Kranenburg MJ, van IJzendoorn MH. A gloomy picture: a meta-analysis of randomized controlled trials reveals disappointing effectiveness of programs aiming at preventing child maltreatment. BMC Public Health. 2015 Oct 18;15:1068. doi: 10.1186/s12889-015-2387-9.

  PMID: 26476980 BACKGROUND

• Vlahovicova K, Melendez-Torres GJ, Leijten P, Knerr W, Gardner F. Parenting Programs for the Prevention of Child Physical Abuse Recurrence: A Systematic Review and Meta-Analysis. Clin Child Fam Psychol Rev. 2017 Sep;20(3):351-365. doi: 10.1007/s10567-017-0232-7.

  PMID: 28378136 BACKGROUND

• Kling A, Forster M, Sundell K, Melin L. A randomized controlled effectiveness trial of parent management training with varying degrees of therapist support. Behav Ther. 2010 Dec;41(4):530-42. doi: 10.1016/j.beth.2010.02.004. Epub 2010 Oct 1.

  PMID: 21035616 BACKGROUND

• Stattin H, Enebrink P, Ozdemir M, Giannotta F. A national evaluation of parenting programs in Sweden: The short-term effects using an RCT effectiveness design. J Consult Clin Psychol. 2015 Dec;83(6):1069-1084. doi: 10.1037/a0039328. Epub 2015 May 25.

  PMID: 26009784 BACKGROUND

• Chen M, Chan KL. Effects of Parenting Programs on Child Maltreatment Prevention: A Meta-Analysis. Trauma Violence Abuse. 2016 Jan;17(1):88-104. doi: 10.1177/1524838014566718. Epub 2015 Jan 8.

  PMID: 25573846 BACKGROUND

• Lundahl BW, Nimer J, Parsons B. Preventing Child Abuse: A Meta-Analysis of Parent Training Programs. Research on Social Work Practice, 16(3): 251-262, doi: 10.1177/1049731505284391. Epub 2006.

  BACKGROUND

• Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.

  PMID: 19897823 BACKGROUND

• van Leuven L, Enebrink P, Ghaderi A, Sorjonen K, Lalouni M, Forster M. A randomized controlled trial of Safer Kids - A program for parents reported for child abuse: Short-term effects on further reports of child abuse and related risk factors. Child Abuse Negl. 2023 Sep;143:106329. doi: 10.1016/j.chiabu.2023.106329. Epub 2023 Jun 27.

  PMID: 37384960 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Martin Forster, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized to the control condition (intervention as usual) or the experimental condition (intervention as usual + Safer Kids - manualized parent training)

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 14, 2019
• Study Start: November 15, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (30)