Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065936
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-08-01
Brief Title:
Self-Injury Diagnosis and Treatment
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Behavioral and Biochemical Mechanisms of Self-Injury
Status:
UNKNOWN
Status Verified Date:
2003-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 ie 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
Participants with mild to profound mental retardation andor 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NICHD-0525 | None | None | None |
| R29 HD35862 | None | None | None |