Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT07168460
Brief Summary:
The purpose of this project is to investigate whether trained social service dogs can increase students' school attendance and school motivation, and ultimately contribute to students reaching the basic learning goals. Main research questions are:
1. What are the effectiveness and cost-effectiveness of having social service dogs support at schools to improve learning outcome and school attendance in students with problematic school absence?
2. What are the risks to the health and well-being of those social working dogs when they work in the school environment as well as the challenges in bringing dogs to the schools?
Researchers compared the intervention group which consisted of students supported by social working dogs, to the control group of students supported by special education teachers. Participants were assigned to each group randomly. Students from each group met the support teams for 30 minutes per session, twice per week for 10-12 weeks. During the intervention, children had physical contact with dogs as much as they wished and on consideration of dogs' welfare. The dog handler carried out some pedagogical tasks, such as children reading to the dog while the dog was next to the child or when its head was on the child's lap. The dog handlers documented the process of each session and observed the children on their educational tasks. Children in the control group met special education teachers and received pedagogical tasks involving Swedish, mathematics, etc. Similar to the dog team, special education teachers documented the process and observed the performance of children's educational tasks.
Detailed Description:
The aim of this project is to investigate whether an intervention delivered by trained social working dog teams can increase school attendance among school-age children in grades 3-9, contribute to children achieving the basic learning goals, and improve health-related quality of life. The study design is an individually-randomized controlled trial with two arms - intervention and control. Randomization is conducted at the individual level within each school through lottery. Schools in Sweden were contacted by sending out flyers. Principals who wanted their schools to participate in the project contacted the project manager. The selection criteria for inclusion in the project are children from grades 3-9 with at least 15% absence from school during at least one semester, receiving no additional support.The criteria for exclusion are as follows: children who had 50%-100% absenteeism for more than a year; children who were severely allergic to dogs or who had previous negative experiences with dogs; and children from grades 1-3. Additionally, children who had previously participated in an intervention with a social working dog were excluded, as the potential impact on the results is unknown. Participation was voluntary, and written consent forms from both children and parents/ guardians were obtained. The study population includes school-age children from grades 3-9 in Sweden. A sample size of around 64 school-going children with a 1:1 allocation was allocated within the schools into control and intervention groups. Primary outcome data were collected at the following time points: T0 - pre-intervention (the whole semester before intervention), T1 - the whole semester during intervention, and T2 - the whole semester after intervention. Secondary outcome data were collected at T0 - pre-intervention, T1 - immediately post intervention, T2 - 3 months post intervention, and T3 - 6 months post intervention.
Study:
NCT07168460
Study Brief:
Protocol Section:
NCT07168460