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

NCT05135780 | Unknown

• 1 other identifier: 26102021
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopathic Medicine; Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Osteopathy sessions

  july 2022

• Change in Numerical Pain Scale

  At baseline and second measure at July 2022

Interventions

Osteopathic manual treatment OTHER

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 OTHER

* 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.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Francesco Cerritelli: lead
• Come Collaboration: collaborator
• Fundació Albert Salut i Educació: collaborator

Study Sites (1)

Sonia Roura Carvajal

La Seu d'Urgell, 25700, Spain

RECRUITING

Study Officials

• Sonia Roura Carvajal, MsC

  Sonia

  STUDY DIRECTOR

Central Study Contacts

Sonia Roura Carvajal, Msc

CONTACT

+34619789589; soniaroura6@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of Come Collaboration

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 26, 2021
• Study Start: November 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

ES (1)