Clinical Trial: Short Stature Related Distress
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Influence of Growth Hormone (GH) Therapy on Short Stature Related Distress a Prospective Randomized Controlled Trial
Brief Summary: The research aims to provide data on gender-related psychological impact of GH (Growth Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the study, the investigators aim to provide descriptive documentation of the unique distress signal manifestation implicitly shown by ISS (idiopathic short stature)boys and suggest methods of early detection and measurement of such manifestations that can be used to cement guidelines for the treatment in GH.
Detailed Summary:
Study Design:
A prospective randomized, double blind, placebo controlled trial design, comparing four research groups, with 4 repeated psychological measures (before treatment, after 3 months,after 1 year, and at the end of treatment, after 4 years).
The study will be divided into two segments:
Segment 1:double blind, placebo controlled, will include the first 60 ISS (Idiopathic Short Stature)recruited patients. Patients in this segment will be randomized to one of the growth hormone treatment groups in a ratio of 2:1. 40 patients will be treated 4 years with GH and 20 patients will be treated with placebo at the first year of the study and will have the option to start GH treatment after one year, for a duration of 3 years.
Segment 2:after the enrollment to segment 1 will end, enrollment to segment 2 will begin.Participants in segment 2 (patients with ISS and short stature) will serve as control groups and therefore will not be treated with growth hormone.
in addition,30 boys with normal stature will serve as a second control group.
The 4 repeated psychological evaluations (before treatment,after 3 months, after 1 year, and at the end of treatment, after 4 years)will include:
- Implicit Association Test
- Masculine Self Image
- Pictures Projective Test
- The Rosenberg Self Esteem Scale-a self report measure of explicit self- esteem
- Quality of Life Questionnaire
- SAT- a self report m
Sponsor: Rabin Medical Center
Current Primary Outcome: Distress score [ Time Frame: After 4 years of treatment ]
short stature related distress score as measured by the psychological evaluation
Original Primary Outcome: short stature related distress score [ Time Frame: After 4 years of treatment ]
short stature related distress score as measured by the psychological evaluation
Current Secondary Outcome: Perceived self image score [ Time Frame: After 4 years of treatment ]
Perceived self image score as measured through the psychological evaluation
Original Secondary Outcome: Same as current
Information By: Rabin Medical Center
Dates:
Date Received: November 16, 2010
Date Started: October 2011
Date Completion: December 2017
Last Updated: January 10, 2017
Last Verified: January 2017
