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Completed

NCT Number: NCT01246219

Short Stature Related Distress

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 Idiopathic Short Stature (ISS) boys and suggest methods of early detection and measurement of such manifestations that can be used to cement guidelines for the treatment in GH.

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Key information

Age range

8 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Schneider Children's Medical center

Petah Tikva, 49202, Israel

About this study

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. Patients in Segment 2 will be evaluated only once.

The 4 repeated psychological evaluations (before treatment,after 3 months, after 1 year, and at the end of treatment, after 4 years)will include the following:

  • 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
  • Silhouette Apperception Technique (SAT)- a self report measure assessing children's and adolescent's perception of their own body size compared with that of their age-related peers
  • Child Behavior Checklist

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1 Segment 1 :Boys at the age range of 8-13 years 2. Segment 2: Boys at the age range of 12-17 years 3. Tanner stage 1 (segment 1 only) 4. more than 2 SD's (standard deviation) below the average height

Exclusion criteria

  • Mental retardation,
  • Psychiatric illness,
  • Lack of informed consent\\assent.
  • Health status that required chronic treatment with steroids

Treatment and study plan

GH treatment (Genotropin)

Drug

4 years treatment with GH

1 year treatment with placebo followed by optional 3 years of GH treatment

Drug

1 year treatment with placebo followed by optional 3 years of GH treatment

Primary outcomes

  1. Psychological Distress score

    Time frame: After 4 years of treatment

    short stature related distress score as measured by the Height Perception Pictures Test

  2. Psychological Distress score

    Time frame: After 4 years of treatment

    short stature related distress score as measured by the Rosenberg Self-Esteem Scale

  3. Psychological Distress score

    Time frame: After 4 years of treatment

    short stature related distress score as measured by the Quality of Life questionnaire

  4. Psychological Distress score

    Time frame: After 4 years of treatment

    short stature related distress score as measured by Silhouette Apperception Technique questionnaire

Secondary outcomes

  1. Perceived self image score

    Time frame: After 4 years of treatment

    Perceived self image score as measured through Single Category Implicit Association Test

  2. Perceived self image score

    Time frame: After 4 years of treatment

    Perceived self image score as measured through the Masculine Self Image questionnaire

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

The Influence of Growth Hormone (GH) Therapy on Short Stature Related Distress a Prospective Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 23, 2010
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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