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

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ClinicalTrials.gov Identifier: NCT05135780
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Come Collaboration
Fundació Albert Salut i Educació
Information provided by (Responsible Party):
Francesco Cerritelli, Come Collaboration

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.

Condition or disease Intervention/treatment
Osteopathic Medicine Effectiveness Other: Osteopathic manual treatment Other: Social education

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Change in Pediatric Quality of Life Inventory (PedsQL) questionnaire [ Time Frame: -1rst questionnaire at baseline 2nd questionnaire in December 2021. - 3rd questionnaire in March 2022. - 4th questionnaire in June 2022. ]

    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.

Secondary Outcome Measures :
  1. Number of Osteopathy sessions [ Time Frame: july 2022 ]
    Number of osteopathy sessions needed for each child and/or family.

  2. Change in Numerical Pain Scale [ Time Frame: At baseline and second measure at July 2022 ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes 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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135780

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Contact: Sonia Roura Carvajal, Msc +34619789589 soniaroura6@gmail.com

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Sonia Roura Carvajal Recruiting
La Seu d'Urgell, Spain, 25700
Contact: Sonia Roura Carvajal    619789589    soniaroura6@gmail.com   
Sponsors and Collaborators
Francesco Cerritelli
Come Collaboration
Fundació Albert Salut i Educació
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Study Director: Sonia Roura Carvajal, MsC Sonia
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Responsible Party: Francesco Cerritelli, President of Come Collaboration, Come Collaboration
ClinicalTrials.gov Identifier: NCT05135780    
Other Study ID Numbers: 26102021
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No