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Self-Injury: Diagnosis and Treatment

Primary Purpose

Self-Injurious Behavior, Mental Retardation

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Naltrexone hydrochloride
Transcutaneous sensory nerve stimulation
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-Injurious Behavior focused on measuring Intractable self-injurious behavior, Naltrexone, Transcutaneous electrical nerve stimulation, Substance P, Met-enkephalin, Cortisol

Eligibility Criteria

4 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Frank Porter Graham Child Development Center, University of North Carolina at Chapel Hill
  • Research Training Institute, Western Carolina Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 1, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00065936
Brief Title
Self-Injury: Diagnosis and Treatment
Official Title
Behavioral and Biochemical Mechanisms of Self-Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2003
Overall Recruitment Status
Unknown status
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Injurious Behavior, Mental Retardation
Keywords
Intractable self-injurious behavior, Naltrexone, Transcutaneous electrical nerve stimulation, Substance P, Met-enkephalin, Cortisol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
37 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Naltrexone hydrochloride
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous sensory nerve stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Symons, Ph.D.
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frank Porter Graham Child Development Center, University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Research Training Institute, Western Carolina Center
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10463024
Citation
Symons FJ, Koppekin A, Wehby JH. Treatment of self-injurious behavior and quality of life for persons with mental retardation. Ment Retard. 1999 Aug;37(4):297-307. doi: 10.1352/0047-6765(1999)0372.0.CO;2.
Results Reference
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PubMed Identifier
12475363
Citation
Symons FJ, Sutton KA, Walker C, Bodfish JW. Altered diurnal pattern of salivary substance P in adults with developmental disabilities and chronic self-injury. Am J Ment Retard. 2003 Jan;108(1):13-8. doi: 10.1352/0895-8017(2003)1082.0.CO;2.
Results Reference
background
PubMed Identifier
12756380
Citation
Breau LM, Camfield CS, Symons FJ, Bodfish JW, Mackay A, Finley GA, McGrath PJ. Relation between pain and self-injurious behavior in nonverbal children with severe cognitive impairments. J Pediatr. 2003 May;142(5):498-503. doi: 10.1067/mpd.2003.163.
Results Reference
background

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Self-Injury: Diagnosis and Treatment

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