Istituto Auxologico Italiano
Milan, 20145, Italy
NCT Number: NCT06295341
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.
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Notify Me6 year–14 year
All sexes
Observational
Milan, 20145, Italy
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:
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
age between 6 and 14 years, of both sexes
Exclusion criteria
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).
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.
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.
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.
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.
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).
Istituto Auxologico Italiano
Other
Acronym: PSICOSHORT
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