NCT05135780

The Quality of Life in Children at Social Risk, a Case Series Study Protocol

Phase Project (Fundació Albert Salut i Educació): Effects of a Multidisciplinary Intervention (Osteopathy and Social Work) on the Quality of Life in Children at Social Risk. A Case Series Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Francesco Cerritelli · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: —

Summary

this case series study has the aim to observe the effect of a multidisciplinary intervention (social accompaniment, school reinforcement and osteopathic treatment) on the quality of life of children with social risk in primary school age.

Detailed description

To observe the effect of a multidisciplinary intervention (social accompaniment, school reinforcement and osteopathic treatment) on the quality of life of children with social risk in primary school age. II. Secondary objectives * Observe if the quality of life of children in whom an osteopathic intervention is performed to the family, improves in relation to children who are not treated to the family. * Observe if the number of sessions has any impact on the evolution of the quality of life of children. * Observe whether age is an influential factor for improving children's quality of life. * Observe the possible confounding factors that may influence the evolution of children's quality of life. These factors are detailed later in the section on secondary variables. * Observe if there is a decrease in pain, in children who refer it. * Observe if there is an improvement in the different reasons for consultation. * The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona. * Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk. * The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly. * The Covid protocol that is in force during the start of the study will be taken into account. * The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona. * Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk. * The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly. * The Covid protocol that is in force during the start of the study will be taken into account. * The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona. * Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk. * The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly. * The Covid protocol that is in force during the start of the study will be taken into account. * The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona. * Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk. * The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly. * The Covid protocol that is in force during the start of the study will be taken into account. * The coordination of the study and its different interventions will be carried out from the AF. Carrer Consolat de Mar, 45. Barcelona. * Osteopathic intervention will be performed in AF. It is decided to move the Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to bring the solidarity service closer to a more appropriate and closer district for the patient at social risk. Having to move outside their environment, taking public transport, language problems and comparative grievances with the utilitarians of a private service turned out to be reasons for absenteeism and lack of commitment. The transfer has been a success and we believe it is convenient to carry out the study within the FA to preserve the location of the project and the comfort/safety of users at social risk. * The participating families will be referred, as is usually worked in this foundation, by the Social Services Centers, other agents and social entities, CSMIJ (Center for Mental Health of Children and Youth), CDIAP (Center for Development and Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance directly. * The Covid protocol that is in force during the start of the study will be taken into account.

Conditions

• Osteopathic Medicine
• Effectiveness

Interventions

Type	Name	Description
OTHER	Osteopathic manual treatment	Between 5 and 8 sessions of osteopathy will be carried out, and the time interval between sessions may vary depending on the need and individual evolution of each child, assessed by the team of osteopaths.
OTHER	Social education	* Intervention in children: * During the school year there will be activities of two days per week with a duration of 2.5 hours per session in the afternoon. * The activities will focus on school reinforcement, facilitating snacks and having a recreational space. * Groups will be made by age ranges (from 4 to 6 and from 7 to 12) of maximum 10 children, due to the current COVID situation. The number could vary in the event of a change in measures at the institutional level. * Family intervention: * Quarterly tutoring spaces between the coordinators and the team of social educators to evaluate needs, specify objectives and assess evolution. * Monthly group spaces for mothers managed by the team of educators where they will exchange experiences and create an informal support network. * Monthly spaces shared between parents and children accompanied by the educational team, where family ties will be worked through play.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-11-26
• Last updated: 2021-11-26

Locations

1 site across 1 country: Spain