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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteopathic Medicine; Effectiveness
• Intervention / Treatment: Other: Osteopathic manual treatment; Other: Social education

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Sonia Roura Carvajal, Msc; Phone Number: +34619789589; Email: soniaroura6@gmail.com

Study Locations

• Spain
  • La Seu d'Urgell, Spain, 25700
    • Recruiting
    • Sonia Roura Carvajal
    • Contact: Sonia Roura Carvajal; Phone Number: 619789589; Email: soniaroura6@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Osteopathy sessions	Number of osteopathy sessions needed for each child and/or family.	july 2022
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

Collaborators and Investigators

• Sponsor: Francesco Cerritelli
• Collaborators: Come Collaboration; Fundació Albert Salut i Educació
• Investigators: Study Director: Sonia Roura Carvajal, MsC, Sonia

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 26102021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No