Pilot Testing on New NHANES 2009-10 Content

Attachment D.

Protocol for Pubertal Maturation Pilot Study (ages 8-18)

National Health and Nutrition Examination Survey (NHANES)

ACASI Pubertal Maturation Pilot Study

OMB no. 0920-0237

Expires: 12/31/2011

Assurance of confidentiality – All information which would permit identification of an

individual, a practice, or an establishment will be held confidential, will be used for

statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).

Public reporting burden of this collection of information is estimated to average 4 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333. ATTN: PRA (0920-0237).

Audio-Computer-Assisted Self-Interview (ACASI) Pubertal Maturation Pilot Study Protocol:

Eligibility: Sample persons aged 8-18 years or older are eligible for the ACASI Pubertal Maturation Pilot Study.

Informed Consent: Informed consent will be obtained as a part of standard NHANES consenting procedures.

Exclusion Criteria: Participants must have good cognitive abilities in order to understand and respond to the questions appropriately. Participants who are blind or have very poor eyesight will be excluded from the component.

Study Design: This is a self-administered questionnaire. Two questions on self-assessed pubertal maturation status will be included. The pilot test may also include 1-2 questions pertaining to the ease/difficulty of selecting body development drawings. The total time required to answer 4 questions is about two minutes. Pubertal maturation questions with accompanying screen shots are in Attachment E. Questions on ease/difficulty of making a selection follow:

1. Was it easy to choose a drawing?

2. Was the computer easy to use?

Data Collection: The topic may be sensitive for many participants. Therefore, an ACASI mode of interview is proposed. Participants will answer questions in a private Mobile Examination Center (MEC) interview room, using a touch screen computer and headphones. Girls will view and select from 4-5 drawings depicting Tanner stages of pubic hair and breast development. Boys will view and select from 4-5 drawings showing Tanner stages of pubic hair and genital development. The number of drawings shown will depend upon the age of the participant.

Report of Findings: Results will not be reported to the participant.