Mental Retardation Clinical Trial
Official title:
Behavioral and Biochemical Mechanisms of Self-Injury
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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