Self-Injury: Diagnosis and Treatment

Mental Retardation Clinical Trial

Official title:

Behavioral and Biochemical Mechanisms of Self-Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00065936
• Other study ID #: R29HD35862
• Secondary ID: R29 HD35862NICHD
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 1, 2003
• Last updated: June 23, 2005
• Start date: July 1997
• Est. completion date: June 2002

Study information

• Verified date: May 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intellectual Disability
• Mental Retardation
• Self-Injurious Behavior

Intervention

Drug:
• Naltrexone hydrochloride

Procedure:
• Transcutaneous sensory nerve stimulation

Locations

Country	Name	City	State
United States	Frank Porter Graham Child Development Center, University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Research Training Institute, Western Carolina Center	Morganton	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation