The Quality of Life in Children at Social Risk, a Case Series Study Protocol (NCT05135780) | Clinical Trial Compass
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The Quality of Life in Children at Social Risk, a Case Series Study Protocol
Spain20 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring changes in quality of life using something called the PedsQL questionnaire — can you explain what that tool actually measures, and whether it's a good fit for tracking my child's specific situation?
2Since this is listed as a 'case series' study rather than a randomized controlled trial, what does that mean for how reliable the results will be, and should that affect whether we take the findings seriously?
3The trial involves osteopathic medicine for children at social risk — can you help me understand what osteopathic treatments would actually be involved, and whether there's any evidence they're appropriate for my child's needs?
4The recruitment status for this trial is listed as unknown, so can you check whether it's still actively enrolling, and if not, are there similar studies we could look into instead?
5Before considering any research study like this one, would you recommend we first try standard care options for my child's quality of life concerns, or do you think a study like this could be worth exploring alongside regular treatment??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.