Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

BEHAVIORAL

Optimize Sleep Primary Care (OSPC)

In addition to standard care within Temple University Primary Care (TUPC), two face-to-face zoom sessions and four brief phone follow-ups (two during active treatment and two during maintenance) that focus on using effective behavioral strategies (e.g., goal setting, self-monitoring, positive reinforcement, stimulus control, problem-solving) to enhance children's sleep by approximately one hour/night.

OTHER

Enhanced Usual Care

In addition to standard care within Temple University Primary Care (TUPC), the provision of six education contacts regarding children's sleep needs and the benefits of getting a good night's sleep.

Achievement of enrollment goal

Time frame: baseline

Primary variable of interest is achievement of a priori goals for study enrollment (i.e., whether 50 families enroll in the study). We will also explore: of children referred, the number who enroll; and of children who are referred and eligible, the number who enroll.

The number of providers who participate and refer to the intervention

Time frame: baseline

Of all pediatric providers in the clinic, the number who attend the initial in-service training and the number of referrals each provider makes to the program. Attendance and the number of referrals will be tracked by study staff.

Average family attendance at intervention sessions

Time frame: baseline to 6 months

Whether or not families attend each treatment sessions will be captured by the study nurse. Primary variable of interest is whether families, on average, achieve \> 75% attendance at all intervention sessions.

Nurse percent fidelity/accuracy in delivering the intervention

Time frame: baseline to 6 months

All intervention sessions are recorded to determine the accuracy with which nurses deliver the intervention. Specifically, trained staff review recordings and use a checklist to mark whether or not each intervention component is delivered during each session. Primary variable of interest is whether the nurse delivers the intervention with at least 80% fidelity/accuracy.

Percent of families who are retained in the study at both follow-up time points

Time frame: baseline to 6 months

Retention at both 2- and 6-months will be tracked by study staff and compared across study arms with a goal of at least 80% retention at two months.

Family assessment of the intervention's acceptability

Time frame: baseline to 6 months

Acceptability will be measured by families' responses to the overall acceptability question on the Theoretical Framework for Acceptability (TFA) Acceptability Scale. Specifically, families use a 5-point, likert-type scale ranging from 'completely unacceptable' to 'completely acceptable' to rate the intervention. The percent of families who rate the intervention as 'acceptable' or 'completely acceptable' will be assessed with a goal of at least 80% of families rating it as such.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.