Protocol Form Examples

Research Protocol - Example 1
Purpose:
To adapt and pilot Attachment-based family therapy for depressed and suicidal
adolescents for repairing attachment ruptures between non-depressed, non-suicidal lesbian,
homosexual and bisexual (LGB) adolescents and young adults and their parents.
Sample:
20 LGB adolescents/young adults ranging in age from 15-35 who report that their
parents have known definitively of their minority sexual orientation for at least 6 months
and that at least one parent rejects their sexual orientation. Both the adolescent/adult child
and his/her parent(s) must consent in order to be included in the study. Exclusion criteria
include use of drugs, history of psychosis, impaired mental capacity (e.g., retardation),
current or recent (last 6 months) significant suicidal ideation or behavior.
Procedure:
Recruitment and inclusion/exclusion criteria. Potential participants will be recruited

through ads placed on the internet and on bulletin boards, as well as through word of
mouth. Individuals who call will receive general information about the study on the phone.
Those interested will be invited in for an intake evaluation. The intake will include a
structured diagnostic interview (i.e., SCID) and a more detailed description of the study.
Those individuals meeting criteria will be consented (see attached consent form).
Measurement. Adolescents/adult children will complete a set of self-report

questionnaires at the end of the intake evaluation, after 6 weeks of therapy and after 12
weeks of therapy. The questionnaires include a measure of depressive symptoms (BDI),
general symptoms (Brief Symptom Inventory; BSI), measures of perceived parenting
behaviors (CRPBI), attachment (PBI and ORI), quality of child-parent relationship, child-
parent conflict (Parent Child Tactic Scale), internalized homophobia/lgb development (LGIS)
and four open-ended questions about parental acceptance of their LGB status. Parents will
complete a measure of personality symptoms (PDQ), a measure of attachment toward their
own parents, prior to treatment (i.e., during the intake evaluation). In addition, parents will
complete four open-ended questions regarding their level of acceptance of their child's LGB
status before and after treatment. Finally, both adolescents/young adults and their parents
will participate in a qualitative interview about their experience in treatment at the end of
treatment.
Therapy. Therapy will be given on a once-weekly basis. Sessions will last

approximately one hour. All therapy will be administered by Gary M. Diamond, Ph.D., a
licensed clinical psychologist and family therapist and one of the primary developers of ABFT
or Maya Shpigel, M.A., a clinical psychology intern supervised by Dr. Diamond. The course of
therapy will be between 12 and 24 weeks, depending on the unique clinical demands of the
case. The first sessions involve meeting alone with the adolescent/adult child separately and
parent separately. These sessions involve alliance building. In the mid-stage of therapy,
conjoint sessions focus on repairing attachment. The final stage of therapy involves
consolidation and commitment to relationship in future. This therapy has been successfully
tested for LGB suicidal adolescents in previous trials funded by the American Foundation for
Suicide Prevention and the US Center for Disease Control. The procedures and results for
these studies have been published in detail elsewhere (see Diamond et al., 2010 for
example). All therapy sessions will be videotaped.
For those clients needing or requesting additional therapy after their course of
treatment in the study, referrals will be made to area mental health clinics, family therapy
clinics and private therapists. All clients will receive at least one referral to each type of
setting mentioned above.
Safety procedure: Since this is not a depressed population, and since individuals with
significant suicidal ideation will be excluded from the study, we do not expect any medical
emergencies. However, to err on the side of precaution, clients will have access to Dr.
Diamond's cell phone number, which is active 24 hours a day. Moreover, any indications of
severe psychological distress during the therapy will be explored and, if necessary,
appropriate referrals for concurrent therapy/psychiatric consultation will be made.
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1. Research Design
The goal of this research is to gain some insight into the role of rationality in decision
making. The research to be conducted under this protocol falls under the general
heading of behavioral economics (experimental economics), which contrasts
behaviors in simple computerized environments with predictions of classic economic
theory. Examples of the experiments include the ultimatum game, the dictator game,
and the prisoner dilemma game.
Games rules will be manipulated to identify factors that influence people to make
decisions that are either more or less rational. For example, in dictator games the first
of two players, the proposer, divides an amount of money (the pie or cake) between
the two players. The other player, the responder, can only accept the decision and
amount of money allocated to him or her. This game can be manipulated by varying
the social distance between the two players, by repeating the game with the same two
players multiple times, or by asking players to first write down how they would
respond if they were the other player. As another example, the participant might hear
a high-pitched sound for 10 seconds and be asked how much they would have to be
paid to spend 30 seconds listening to this sound again (we have used these sounds for
years and they are low intensity but slightly annoying).
The protocol will be implemented in two setting: 1) decision making lab, or 2) in

public places. The lab-based experiments will be the more complex and longer
experiments, while the experiments executed at public places will be simpler and
shorter (about 10 min). All of the information about the particular games, including
rules of the game and payment will be provided to participants before they begin
playing.
Lab-based protocol:
The first screen of the computer will present the consent form with a button at the
bottom of the screen that indicates that the participant has read the instructions and
would like to continue. Once the participants move to the next screen, they will be
presented with the exact rules for the game they are about to play.
Games are incentive compatible, which means that all participants will know in
advance what the rules for payment are, and how different outcomes of the games will
be translated into different levels of payment. At the end of a game, participants will
be paid according to the pre-specified payment rule, and thanked for their
participation.
Examples of games that will be played are the prisoner dilemma game, the ultimatum
game, the matrix game, etc. For example, in the ultimatum game, one individual is
given $10 and is asked to allocate any amount from this $10 to a second player. If the
second player accepts the offer they both get their allocation, and if the second player
rejects the offer the money returns to the experiments (and of course all the rules are
known in advance). In the matrix game, the respondents are given a set of shapes and
within a short time are asked to find the two that match best. Correct answers are
rewarded by a known $ amount and wrong answers are punished by a known $
amount.
Public spaces protocol

For very short games (about 10 min) the protocol will be carried out in public spaces,
such as the Student Center, with a large sign announcing the experiment and the
expected pay (for example “make up to $5 for 5 min of your time”). These
experiments will be all computer-based with almost no intervention from the
experimenter – who will simply point the potential participants to the computer,
answer questions if any arise, and pay the participants the amount shown on the
screen at the end of the experiment.
The first screen of the computer will present the consent form (see below) with a
button at the bottom of the screen that indicates that the participant has read the
instructions and would like to continue. At the end of a game, participants will be paid
according to the pre-specified payment rule and thanked for their participation.
2. Subject Selection
For the studies in the decision making lab, subjects will be recruited through standard
procedures including fliers around campus and emails to students who are listed in
subject pools.
Subjects recruited in public spaces will include anyone interested in participating as
long as they are at least 18 years old.
3. Risks and Benefits

There are no potential risks and no anticipated benefits to individual participants.
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Research protocol
The present study evaluates hazard perception training programs for young-inexperienced
drivers. All young-inexperienced drivers will undergo a training session. In the training
session, each participant will be designated to one of four experimental conditions based on
his or her gender, demographics and sensation seeking score (Zuckerman M, 1994).
Approximately a week later participants will undergo a hazard perception test session. The
test includes two sections: 1) a computer based session; 2) simulated driving session.
In the computer based test session participants will be asked to observe various traffic
scenarios and to press a response button each time they detect a hazard. The drivers will
then observe six additional hazard perception movies and will be asked to classify them into
an arbitrary number of groups according to the similarity in their hazardous situations. During
this section drivers they are connected to an eye tracking system
In the simulated driving session, drivers will first have a short adaptation experience to the
simulator in order to get familiar with the driving simulator's steering wheel and pedals.
Then, drivers will be asked to drive several traffic-scenarios of approximately 20 minutes.
Participants
Participants will be 52 young-novice drivers (17-18 year-olds with an average) with less than
three months of driving experience.
High school students will be randomly recruited from the city of Beer-Sheva (via newspapers
ads and mouth-to-ear) where our labs are located.
Each participant will be asked to sign a consent form and parental agreement if the
participant is under the age of 18.
In addition, each participant will be asked to fulfill a demographic questionnaire in which

data regarding his or her socio economic status will be collected (such as, does he or she
have a car, do their parents own one, amount of driving they did, etc.)
Participants will receive monetary compensation of 60NIS for the training phase (1.5 hours)
and 80 NIS for the testing phase (two hours).
Apparatus
Facilities
Two main locations will be used: (1) the eye movements’ laboratory in which drivers will be
trained and then tested on their HP abilities while connected to an eye tracking system and
(2) the driving simulator in which drivers will be further evaluated on their performance in
actual driving.
 The eye movements’ laboratory includes an ASL D6 heads-free (the participant is not
wearing any equipment on himself) eye tracking system. D6 is able to track a user’s
eye movements at a rate of 60Hz without any limitation on the user’s head
movement. The D6 is designed to track eye movements on a single plane. The D6
meets with all safety standards (see appendix 3.4)
 The STISIM is a non-moving base driving simulator. The Driving simulator Lab consists
of a brand-new Cadillac and a 180 degrees rounded screen to display a wide field of
view of the driving scenarios.

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Research Protocol - Example 1

Recruitment and inclusion/exclusion criteria. Potential participants will be recruited

Measurement. Adolescents/adult children will complete a set of self-report

Therapy. Therapy will be given on a once-weekly basis. Sessions will last

Scroll down for more examples

The protocol will be implemented in two setting: 1) decision making lab, or 2) in

Public spaces protocol

3. Risks and Benefits

Scroll down for more examples

In addition, each participant will be asked to fulfill a demographic questionnaire in which

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