Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295341
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-28
Brief Title:
Short Stature and Psychological Well-being
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Short Stature and Psychological Well-being
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSICOSHORT
Brief Summary:
The first aim of the present study is to evaluate the psychological impact of the condition of short stature family in a sample of Italian children comparing them with subjects of normal stature measuring their levels of psychological well-being psychological distress quality of health-related life and any behavioral issues The secondary objective is to study the psychological impact evaluated with the tests described below see methods section in children with GH deficiency and the effects of replacement therapy 6 months with GH from recombinant DNA
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 velocityyear -10 SD for age and sex evaluated at least 6 months apart and peak GH at two different pharmacological stimulus tests 8 ngml 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 0025-0035 mgkg of body weight per day or 07-10 mgm2 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 hyperactivityinattention 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
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 velocityyear -10 SD for age and sex evaluated at least 6 months apart and peak GH at two different pharmacological stimulus tests 8 ngml 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 0025-0035 mgkg of body weight per day or 07-10 mgm2 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 hyperactivityinattention 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None