Trial record 19 of 20 for:    autism, "eunice kennedy shriver national institute of child health and human development"

Self-Injury: Diagnosis and Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00065936
First received: August 1, 2003
Last updated: June 23, 2005
Last verified: May 2003
  Purpose

Self-injurious behavior is behavior in which a person hurts or harms himself. This behavior sometimes occurs in people with mental retardation or autism. This study will evaluate self-injurious behavior in people with mental retardation or autism and will test the effectiveness of new treatments.


Condition Intervention Phase
Self-Injurious Behavior
Mental Retardation
Drug: Naltrexone hydrochloride
Procedure: Transcutaneous sensory nerve stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Behavioral and Biochemical Mechanisms of Self-Injury

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 37
Study Start Date: July 1997
Estimated Study Completion Date: June 2002
Detailed Description:

It is unknown why some people with mental retardation and/or autism repeatedly and persistently injure themselves, some to the point of tissue damage and permanent scarring. Unraveling this mystery poses paradoxical biomedical and behavioral science questions and creates deeply troubling problems for practitioners and family members of affected individuals. Over the past decade, many cases of self-injurious behavior (SIB) have been treated successfully using behavioral interventions that teach communication and other functional skills. However, practical problems of implementation, costs associated with long-term treatment, and cases with no clear social profile suggest that there is still much to be learned about why people self-injure. Some forms of self-injury may involve intense stimulation of body sites sufficient to elicit the release and receptor binding of endogenous opioid peptides. This study will evaluate variables common to SIB and the neurophysiology of pain regulation. The study will also clarify the role of the endogenous opioids and pain mechanisms in self-injury.

Participants with mild to profound mental retardation and/or autism will be observed for frequency of self-injury, duration and intensity of self-injurious behavior, and where on the body that behavior is directed. Following this characterization, participants’ saliva will be noninvasively examined for substance P, met-enkephalin, and cortisol as markers for altered pain transmission and predictors of response to treatment. After screening and SIB subtyping (i.e., social, nonsocial, or mixed), 37 participants whose self-injury is primarily nonsocial or mixed will be evaluated over 16 weeks. Participants will be randomized to receive either transcutaneous electric nerve stimulation (TENS, an opioid agonist treatment) or naltrexone (an opioid antagonist treatment). Participants whose self-injury is primarily socially motivated will be evaluated with TENS and will receive behavioral interventions through a technical assistance service delivery model. Follow-up evaluations will occur at Months 3 and 6.

  Eligibility

Ages Eligible for Study:   4 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Self-injurious behavior for at least 3 months prior to study entry
  • Normal cardiac, liver, and kidney function as determined by a physician

Exclusion Criteria

  • Only presenting problems are pica, aggression, property destruction, hyperkinesis, screaming, or eating disorders
  • Lesch-Nyhan syndrome
  • Peripheral neuropathy
  • Self-injury that presents immediate imminent risk such as loss of sight or hearing or other potentially life threatening behavior
  • Serious chronic health impairments associated with specific syndromes (e.g., Cornelia de Lange, Prader Willi Syndrome)
  • Self-injury unresponsive to prior conventional behavioral or pharmacological interventions (e.g., less than 50% reduction in overall self-injury for 3 months)
  • Major depressive disorder or schizophrenia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065936

Locations
United States, North Carolina
Frank Porter Graham Child Development Center, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Research Training Institute, Western Carolina Center
Morganton, North Carolina, United States, 28655
Sponsors and Collaborators
Investigators
Principal Investigator: Frank Symons, Ph.D. University of North Carolina
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00065936     History of Changes
Other Study ID Numbers: R29HD35862, R29 HD35862, NICHD-0525
Study First Received: August 1, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Intractable self-injurious behavior
Naltrexone
Transcutaneous electrical nerve stimulation
Substance P
Met-enkephalin
Cortisol

Additional relevant MeSH terms:
Mental Retardation
Self-Injurious Behavior
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Behavioral Symptoms
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014