Clinical trial NCT05135780: The Quality of Life in Children at Social Risk, a Case Series Study Protocol
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteopathic Medicine
Effectiveness
Lead sponsor: Come Collaboration
Sponsor class: OTHER
Collaborators: name: Come Collaboration
name: Fundació Albert Salut i Educació
First posted: 2021-11-26
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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

Brief 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.

Eligibility criteria: Inclusion Criteria:

* The children will be selected from the set of users of the Albert Foundation with the following criteria:

  * Children from families at social risk, in school and aged between 6 and 12 years of age. The situation of social risk or vulnerability will be determined by the "Instrument de cribratge de les situacions de risc i de desemparament" of the General Directorate of Child Care (DGAIA) of the Generalitat de Catalunya (41), being referred by Social Services, other social entities or that have requested assistance directly.

Exclusion Criteria:

* ○ Families who do not sign consent to participate in the study.

  * The unavailability of families to participate in the study. In some cases, even if there are children who meet the inclusion criteria, they may not have the capacity to participate for reasons outside the AF or/or personal.

Primary outcomes:
measure: Change in Pediatric Quality of Life Inventory (PedsQL) questionnaire
timeFrame: -1rst questionnaire at baseline 2nd questionnaire in December 2021. - 3rd questionnaire in March 2022. - 4th questionnaire in June 2022.
Secondary outcomes:
measure: Number of Osteopathy sessions
timeFrame: july 2022
measure: Change in Numerical Pain Scale
timeFrame: At baseline and second measure at July 2022
Other outcomes:
Locations:
city: La Seu d'Urgell
country: Spain
facility: Sonia Roura Carvajal
Study officials:
affiliation: Sonia
name: Sonia Roura Carvajal, MsC
role: STUDY_DIRECTOR
References: