Short StaturePSICOSHORTNCT06295341
Short Stature and Psychological Well-being
An observational study of Short Stature and Short; Stature, Psychosocial, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Stature, Short; Stature, Psychosocial
- What is being tested?
- Recombinant human growth hormone (only for children with growth hormone deficiency)
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 35 children with familiar short stature, 35 with normal height (height > 25th centile), and 10 with growth hormone deficiency and their caregivers of reference (see above the description of the diagnostic criteria).
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Short Stature, Short; Stature, Psychosocial
- Being tested
- Recombinant human growth hormone (only for children with growth hormone deficiency)
- Keywords
- Short stature, Psychological well-being, Psychological distress, Life quality
- Medical subject headings
- Dwarfism, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human growth hormone (only for children with growth hormone deficiency)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Recombinant human growth hormone (only for children with growth hormone deficiency) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
A 21-item self-report tool that measures various negative internal states: depression, anxiety, and stress.
Measured: 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),
A 50-item domain-specific questionnaire that measures health-related quality of life in children with short stature.
Measured: 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)
A questionnaire made up of 25 items able to assess emotional symptoms, behavioral problems, hyperactivity/inattention, problematic relationships with peers, and prosocial behavior.
Measured: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
Secondary outcomes (1)
Behavioral problems through the Child Behaviour Checklist for Children (CBCL)
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).
Measured: Baseline for the three groups; baseline and after 6 months for the parents of children with growth hormone deficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start10 May 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short StatureStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295341
- Sponsor's protocol ID
- 01C312
- Acronym
- PSICOSHORT
- Status last verified
- Apr 2025
- First submitted
- 28 Feb 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Stature and Psychological Well-being
- ClinicalTrials.gov ID
- NCT06295341
- Acronym / sponsor ID
- PSICOSHORT / 01C312
- Conditions
- Short Stature, Short; Stature, Psychosocial
- Keywords
- Short stature, Psychological well-being, Psychological distress, Life quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: Recombinant human growth hormone (only for 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). |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 35 children with familiar short stature, 35 with normal height (height > 25th centile), and 10 with growth hormone deficiency and their caregivers of reference (see above the description of the diagnostic criteria).
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human growth hormone (only for children with growth hormone deficiency)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). | Drug | cases - children with growth hormone deficiency |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Stature and Short; Stature, Psychosocial, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.