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

Effectiveness Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135780
• Other study ID #: 26102021
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: Come Collaboration
• Contact: Sonia Roura Carvajal, Msc
• Phone: +34619789589
• Email: soniaroura6[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effectiveness
• Osteopathic Medicine

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Sonia Roura Carvajal	La Seu d'Urgell

Sponsors (3)

Lead Sponsor	Collaborator
Francesco Cerritelli	Come Collaboration, Fundació Albert Salut i Educació

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pediatric Quality of Life Inventory (PedsQL) questionnaire	The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of self-report of health-related quality of life in pediatric patients with chronic health conditions. Is a 23-item generic health status instrument. Items are scored from 5-point Likert scale from 0 (Never) to 4 (Almost always) Scores then are transformed on a scale from 0 to 100. Step 1: Transform Score; Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Mean score = Sum of the items over the number of items answered. If 50% or more items are completed: Impute the mean of the completed items in a scale.	-1rst questionnaire at baseline 2nd questionnaire in December 2021. - 3rd questionnaire in March 2022. - 4th questionnaire in June 2022.
Secondary	Number of Osteopathy sessions	Number of osteopathy sessions needed for each child and/or family.	july 2022
Secondary	Change in Numerical Pain Scale	The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).	At baseline and second measure at July 2022