- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06295341
Short Stature and Psychological Well-being (PSICOSHORT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The observational study carried out at the Centre for growth and pubertal Disorders, Istituto Auxologico Italiano, IRCCS, Milan, consists of two sub-projects that involve the recruitment of:
- 70 children, aged between 6 and 14 years, of both sexes: 35 with familiar short stature (height < 3rd centile according to the Italian reference standards) and 35 with normal height (height > 25th centile), of normal weight, and their caregivers of reference. Children with familial short stature will be characterized by: short stature in other members of the family group, not necessarily the parents, harmonious appearance, without particular clinical signs and normal pubertal development, parallel growth curve below the 3rd centile, bone age corresponding to chronological age. Children and teenagers with obesity (BMI > 97th centile) will be excluded
- 10 children, aged between 6 and 14 years, of both sexes, affected by isolated GH deficiency according to the criteria established by AIFA note 39 for this pathology (short stature: ≤ -3 SD or ≤ -2 SD and growth velocity/year ≤ -1.0 SD for age and sex evaluated at least 6 months apart and peak GH at two different pharmacological stimulus tests < 8 ng/ml). The exclusion criterion from the present study (and from treatment with rhGH) will be the presence of organic pathologies at the hypothalamic-pituitary level (assessed by performing brain MRI).
Children with GH deficiency will be evaluated in baseline conditions and after 6 months of therapy with recombinant DNA GH (at a dose of 0.025-0.035 mg/kg of body weight per day (or 0.7-1.0 mg/m2 of body surface area per day).
The following variables will be investigated in the recruited subjects of the two subgroups:
- socio-demographic conditions (gender, age, provenance, level of education, family composition)
- psychological well-being through the Psychological Well-Being Scales (PWB), a self-administered questionnaire consisting of 18 items that investigates the degree of psychological well-being by exploring six dimensions: self-acceptance, positive relationships with others, autonomy, environmental control, personal growth, and purpose of life. The questionnaire consists of 18 items on a 4-step Likert scale.
- psychological distress through the Depression Anxiety Stress Scale (DASS-21), a 21-item self-report tool that measures various negative internal states: depression, anxiety, and stress.
- quality of life through the Quality of Life in Short Stature Youth (QoLISSY), a 50-item domain-specific questionnaire that measures health-related quality of life in children with short stature.
- skills and problems through the Strengths and Difficulties Questionnaire (SDQ), a questionnaire made up of 25 items able to assess emotional symptoms, behavioral problems, hyperactivity/inattention, problematic relationships with peers, and prosocial behavior.
- behavioral problems through the Child Behaviour Checklist for Children (CBCL), a questionnaire to be administered to parents or caregivers of children who are able to detect any behavioral problems. The instrument consists of 113 items that investigate three general scales: total problems, internalizing problems, and externalizing problems and 8 syndromic scales: social withdrawal, somatic complaints, anxiety, depression, social problems, thinking problems, attention problems, antisocial behavior, and aggressive behavior).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alessandro Sartorio
- Phone Number: 2426 +390261911
- Email: sartorio@auxologico.it
Study Locations
-
-
-
Milano, Italy, 20145
- Recruiting
- Istituto Auxologico Italiano
-
Contact:
- Alessandro Sartorio, MD
- Phone Number: 2426 +390261911
- Email: sartorio@auxologico.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: age between 6 and 14 years, of both sexes
- 35 with familiar short stature (height < 3rd centile according to the Italian reference standards) and their caregivers of reference. Children with familial short stature are characterized by: short stature in other members of the family group, not necessarily the parents, harmonious appearance, without particular clinical signs and normal pubertal development, parallel growth curve below the 3rd centile, bone age corresponding to chronological age.
- 35 with normal height (height > 25th centile), aged between 6 and 14 years, of normal weight, and their caregivers of reference
- 10 children, aged between 6 and 14 years, of both sexes, affected by isolated GH deficiency according to the criteria established by AIFA note 39 for this pathology (short stature: ≤ -3 SD or ≤ -2 SD and growth velocity/year ≤ -1.0 SD for age and sex evaluated at least 6 months apart and peak GH at two different pharmacological stimulus tests < 8 ng/ml) and their caregivers of reference
Exclusion Criteria:
- children and teenagers with obesity (BMI > 97th centile) are excluded (for the subgroups with familiar short stature or normal height
- children and teenagers with the presence of organic pathologies at the hypothalamic-pituitary level (assessed by performing brain MRI) (for the subgroup with growth hormone deficiency)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cases - children with familial short stature
- 35 children, aged between 6 and 14 years, of both sexes, with familial short stature (height < 3rd centile according to the Italian reference standards) and their caregivers of reference.
Children with familial short stature will be characterized by: short stature in other members of the family group, not necessarily the parents, harmonious appearance, without particular clinical signs and normal pubertal development, parallel growth curve below the 3rd centile, bone age corresponding to chronological age.
Children and teenagers with obesity (BMI > 97th centile) will be excluded
|
|
cases - children with normal height
35 children, aged between 6 and 14 years, of both sexes, with normal height (height > 25th centile) and weight.
|
|
cases - children with growth hormone deficiency
10 children, aged between 6 and 14 years, of both sexes, affected by isolated GH deficiency according to the criteria established by AIFA note 39 for this pathology (short stature: ≤ -3 SD or ≤ -2 SD and growth velocity/year ≤ -1.0 SD for age and sex evaluated at least 6 months apart and peak GH at two different pharmacological stimulus tests < 8 ng/ml). The exclusion criterion from the present study (and from treatment with rhGH) will be the presence of organic pathologies at the hypothalamic-pituitary level (assessed by performing brain MRI). Children with GH deficiency are evaluated in baseline conditions and after 6 months of therapy with recombinant DNA GH (at a dose of 0.025-0.035 mg/kg of body weight per day (or 0.7-1.0 mg/m2 of body surface area per day). |
6 months of therapy with recombinant DNA GH (at a dose of 0.025-0.035
mg/kg of body weight per day (or 0.7-1.0
mg/m2 of body surface area per day).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological well-being through the Psychological Well-Being Scales (PWB)
Time Frame: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
|
A self-administered questionnaire consisting of 18 items that investigates the degree of psychological well-being by exploring six dimensions: self-acceptance, positive relationships with others, autonomy, environmental control, personal growth, and purpose of life.
The questionnaire consists of 18 items on a 4-step Likert scale.
|
Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
|
Psychological distress through the Depression Anxiety Stress Scale (DASS-21)
Time Frame: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
|
A 21-item self-report tool that measures various negative internal states: depression, anxiety, and stress.
|
Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
|
Quality of life through the Quality of Life in Short Stature Youth (QoLISSY),
Time Frame: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
|
A 50-item domain-specific questionnaire that measures health-related quality of life in children with short stature.
|
Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
|
Skills and problems through the Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
|
A questionnaire made up of 25 items able to assess emotional symptoms, behavioral problems, hyperactivity/inattention, problematic relationships with peers, and prosocial behavior.
|
Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral problems through the Child Behaviour Checklist for Children (CBCL)
Time Frame: Baseline for the three groups; baseline and after 6 months for the parents of children with growth hormone deficiency
|
A questionnaire to be administered to parents or caregivers of children to detect any behavioral problems in their children.
The instrument consists of 113 items that investigate three general scales: total problems, internalizing problems, and externalizing problems and 8 syndromic scales: social withdrawal, somatic complaints, anxiety, depression, social problems, thinking problems, attention problems, antisocial behavior, and aggressive behavior).
|
Baseline for the three groups; baseline and after 6 months for the parents of children with growth hormone deficiency
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01C312
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Short Stature
-
Xiaoping LuoRecruitingChildhood Short StatureChina
-
Belgian Study Group for Pediatric EndocrinologyActive, not recruitingIdiopathic Short StatureBelgium
-
Dong-A ST Co., Ltd.CompletedIdiopathic Short Stature
-
Merck KGaA, Darmstadt, GermanyCompletedIdiopathic Short StatureKorea, Republic of
-
PfizerCompletedIdiopathic Short StatureUnited States
-
Rabin Medical CenterPfizerCompleted
-
BioMarin PharmaceuticalNot yet recruitingIdiopathic Short Stature
-
Novo Nordisk A/SRecruitingIdiopathic Short StatureUnited States
-
University of Erlangen-Nürnberg Medical SchoolCompletedIdiopathic Short StatureGermany
-
Children's Hospital Medical Center, CincinnatiCompleted
Clinical Trials on Recombinant human growth hormone (only for children with growth hormone deficiency)
-
Massachusetts General HospitalGenentech, Inc.CompletedAnorexia Nervosa | Osteoporosis | Osteopenia | Eating DisordersUnited States
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Versartis Inc.Completed
-
CinnagenCompleted
-
Postgraduate Institute of Medical Education and...UnknownChronic Myelogenous Leukemia | Short StatureIndia
-
Columbia UniversityTercicaTerminatedGrowth Hormone DeficiencyUnited States
-
GeneScience Pharmaceuticals Co., Ltd.First Affiliated Hospital, Sun Yat-Sen University; Tongji Hospital; Children's... and other collaboratorsCompletedGrowth Hormone DeficiencyChina
-
TheratechnologiesCompletedHIV Infections | LipodystrophyCanada, France, United States, United Kingdom, Spain, Belgium
-
GeneScience Pharmaceuticals Co., Ltd.Tongji Hospital; Shengjing Hospital; Shandong Provincial Hospital; Children's Hospital... and other collaboratorsRecruiting
-
Weill Medical College of Cornell UniversityGenentech, Inc.SuspendedChronic Renal InsufficiencyUnited States