Child Abuse Clinical Trial
Official title:
Can Children be Protected Against Violence and Violations From Parents? A Randomized Controlled Study of Safer Kids: A Manualized Intervention to Prevent Child Abuse
Verified date | March 2024 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 112 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility | CRITERIA AT START (n = 11 included according to): Inclusion Criteria: - 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. Exclusion Criteria: - 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): Criteria were specified at beginning of inclusion (early spring 2020) to ensure that the intended population of Safer Kids could be recruited. Revised inclusion criteria: 1. 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. 2. The suspected adult lives with the child, at least part time, during the investigation 3. At least one child in the family is between 2-12 years old. Revised exclusion criteria: 1. The events preceding the report does not concern the child between 2-12 years old, only a younger or older sibling 2. The participating caregivers have participated in an intervention concerning abuse of children at the social services in the past 12 months 3. Caregiver and focus child lack residence permit the coming 30 months 4. 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Österåkers kommun | Åkersberga | |
Sweden | Alingsås kommun | Alingsås | |
Sweden | Bjuvs kommun | Bjuv | |
Sweden | Danderyds kommun | Djursholm | |
Sweden | Fagersta kommun | Fagersta | |
Sweden | Gävle kommun | Gävle | |
Sweden | Gislaveds kommun | Gislaved | |
Sweden | Höörs kommun | Höör | |
Sweden | Hörby kommun | Hörby | |
Sweden | Hudiksvalls kommun | Hudiksvall | |
Sweden | Katrineholms kommun | Katrineholm | |
Sweden | Lerums kommun | Lerum | |
Sweden | Lidingö kommun | Lidingö | |
Sweden | Luleå kommun | Luleå | |
Sweden | Mönsterås kommun | Mönsterås | |
Sweden | Örebro kommun | Örebro | |
Sweden | Ronneby kommun | Ronneby | |
Sweden | Skara kommun | Skara | |
Sweden | Skellefteå kommun | Skellefteå | |
Sweden | Söderhamns kommun | Söderhamn | |
Sweden | Södertälje kommun | Södertälje | |
Sweden | Staffanstorps kommun | Staffanstorp | |
Sweden | Stenungsunds kommun | Stenungsund | |
Sweden | Sundbybergs stad | Sundbyberg | |
Sweden | Sundsvalls kommun | Sundsvall | |
Sweden | Täby kommun | Täby | |
Sweden | Tidaholms kommun | Tidaholm | |
Sweden | Botkyrka kommun | Tumba | |
Sweden | Uppsala kommun | Uppsala | |
Sweden | Vellinge kommun | Vellinge |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safer Kids Manual Adherence Rating Scale | After completion of Safer Kids, therapists rate how well they were able to carry out the main parts of each Safer Kids-theme according to the manual. Questions are rated on a 5 point likert-scale (range from 'not at all/not completed' to 'completely according to the manual'). The questionnaire also includes a question of potential obstacles in adhering to the manual. | After completion of Safer Kids | |
Other | Therapist Background Survey | Therapists treating families in the study answer a survey containing questions about their background and education. Therapists educated in Safer Kids also answer two questions pertaining to support from the organisation in working with the intervention. | After starting or completing treatment with first study family | |
Primary | 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) | |
Primary | 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 | Change in Parent Anger Scale (PAS) | An instrument that measures caregivers anger directed at their child. The instrument includes two subscales; experienced anger and expressed anger. In this study, only the first subscale will be used, since the second includes questions regarding violent acts towards children. | Pre (0 month), Post (4 month) and Follow-up (7 month) | |
Secondary | Change in Perceived stress scale (PSS) | The scale will be used to measure parental stress. This is a frequently used scale consisting of 10 items in this version, which measures perceived stress. | Pre (0 month), Post (4 month) and Follow-up (7 month) | |
Secondary | Change in Patient Health Questionnaire (PHQ-9) | The scale will be used to measure parental level of depression (9 items), which is a well known risk factor for child abuse. | Pre (0 month), Post (4 month) and Follow-up (7 month) | |
Secondary | Change in The Strength and Difficulties Questionnaire (SDQ) | To measure the well-being of the child, the caregivers in the study will complete the SDQ - 20 items. | Pre (0 month), Post (4 month), Follow-up (7 month), long-term follow-up (18 and 30 month) | |
Secondary | Change in Kindl-R | The children who participate in the study will be interviewed by the practitioner. The interviews are structured and based on the Kindl-R, which is a scale that the practitioner will help the child to complete. The scale measures quality of life and in this study a few subscales will be included (total 8 items). | Pre (0 month), Post (4 month) and Follow-up (7 month) | |
Secondary | Change in The Alabama Parenting Questionnaire | Seven items will be used to measure the quality of the relationship between the caregivers and the child. The scale will be administrated to the parents. | Pre (0 month), Post (4 month) and Follow-up (7 month) | |
Secondary | Change in The Adult Child Relationship Scale (ACRS) | Also this scale is rated by the caregivers and will be used to measure the quality of the relationship between the caregivers and the child. The sub-scale measuring the level of warmth in the relationship will be used. | Pre (0 month), Post (4 month) and Follow-up (7 month) | |
Secondary | Client Satisfaction Questionnaire (CSQ-8) | Caregivers rated CSQ-8 to assess satisfaction with the help they received from the social services. | Follow-up (7 month) | |
Secondary | Practitioner Acceptability Questionnaire | A 7-item instrument pertaining to satisfaction of interventions was developed by the research group and administered to social workers. The questions concerned social workers view on intervention quality and helpfulness. Items were rated on a 4 point likert-scale. If the family did not receive any services, a fifth option 'no support/interventions' were checked. | Follow-up (7 month) | |
Secondary | Change in AUDIT-C | A 3-item questionnaire concerning alcohol consumption. Parents rate both regarding their own habits and the child's other guardian. | Pre (0 month), Post (4 month) and Follow-up (7 month) | |
Secondary | Change in GAD-7 | A well-established 7-item instrument rated by parents to assess worry and/or anxiety. | Pre (0 month), Post (4 month) and Follow-up (7 month) |
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