Neonatal Intensive CareNCT06488196
Feasibility, Acceptability, and Fidelity of Motivational Interviewing to Increase Maternal NICU Presence
A study testing Motivational Interviewing and Treatment As Usual in people with Neonatal Intensive Care, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial summary
Maternal presence in the NICU during an infant's hospitalization is critical for the infant's medical recovery and overall neurodevelopmental trajectory. However, despite the importance of maternal presence in these settings, the current literature shows that families are often absent at bedside. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Intensive Care
- What is being tested?
- Motivational Interviewing and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2018to 9 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English- or Spanish-speaking mothers >18 years-old with a NICU-hospitalized infant
Who cannot join
- Suicidality, cognitive disability preclude consent/participation, or psychotic/manic symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Feasibility, Acceptability, and Fidelity of Motivational Interviewing Targeting Ethnically-, Linguistically-, and Racially-diverse Mothers' Neonatal Intensive Care Unit (NICU) Bedside Presence
Maternal presence in the NICU during an infant's hospitalization is critical for the infant's medical recovery and overall neurodevelopmental trajectory. However, despite the importance of maternal presence in these settings, the current literature shows that families are often absent at bedside. To date, no behavioral interventions have been conducted to promote increased maternal visitation patterns in NICU settings. This project will aim to fill this gap in the literature by conducting a pilot study that uses a motivational interviewing intervention with the aim of increasing maternal visitation rates to a level IV NICU.
Read the detailed description
This study will be conducted as a randomized controlled pilot trial of a motivational interviewing intervention. Mothers will be contacted for enrollment in the study within the first 48-72 hours of the infant's NICU admission. Contact with the mother will occur in-person within those first 48-72 hours of admission. If mother is unavailable in person within the first 72 hours, a telephone call will be made to her. Should the mother agree to participate in the study, written consent will be obtained if the meeting is taking place in person. If the first contact takes place via telephone, then verbal consent alone will be obtained at that time followed by written consent during the first in-person meeting with mother (see below for detailed consent procedures). Once enrolled, the mother will be assigned to one of two study arms - the treatment group or the treatment-as-usual (comparison) group. Mothers will not be provided with information about study arm assignment.
Cluster randomization: Group assignment will be determined by location of the infant in the NICU. The comparison group will be assigned to the North side of the unit while the treatment group will be assigned to the South side of the unit. Assignment to each side of the unit (i.e., North or South) is routinely determined based on census capacity/availability and not based on other factors that may inhibit the randomization process.
Both study groups will receive 6 sessions with the experimental group receiving motivation interviewing (MI) and the control group receiving support as usual. Additional supportive interventions will continue as needed and determined by the clinical needs and consistent with current treatment as usual (TAU). All families will also complete a discharge study visit within 7 days of NICU discharge; hence, participants will receive a total of at least 7 study visits throughout infant's hospitalization. The goal of the first session will be to establish rapport and obtain information about the sources of stress and distress to target in later sessions. Weekly follow-up visits with all families will continue utilization of supportive and problem-solving approaches to manage stressors identified in the initial session. If mothers cannot be reached in person for projected visits at various time points, attempts will be made to connect with mothers via telephone irrespective of study assignment.
More specifically, the first consultation will consist of a semi-structured clinical interview that will assess the following general topics: (1) family-reported psychosocial factors related to the perinatal period (i.e., antepartum, labor/delivery, postpartum, NICU hospitalization, possible NICU discharge periods); (2) perceptions of the caregiver-infant relationship; (3) family psychosocial stressors; (4) family adjustment to the NICU setting; (5) family self-report of coping; (6) family self-report of barriers to visiting the NICU.
All sessions will be audio-recorded in the treatment arm of the study while a portion of the sessions will be recorded in the comparison group (see data analysis section). All audiotaped sessions will be reviewed for fidelity to motivational interviewing treatment protocol by an MI-certified trainer for English sessions while the Spanish sessions will be reviewed by a doctoral-level graduate student with training in MI and under the supervision of the certified trainer reviewer.
However, if mother does not finish the questionnaires by the end of the visit/contact, she may be asked to stay longer at the unit or on the phone to complete the remaining questions. If she does not have time to complete the questions, the investigators will develop a plan for completing the remaining questions. For instance, the investigators may ask to contact her via phone within the next five days in order to read and complete the remaining questions or meet again during the next visit to the NICU.
- Conditions
- Neonatal Intensive Care
- Being tested
- Motivational Interviewing, Treatment As Usual
- Keywords
- motivational interviewing, NICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivational interviewing (MI) is a person-centered, goal-oriented psychotherapeutic intervention designed to enhance the recipient's motivation for and commitment to a target behavior or behavior change. MI's core action mechanisms include strengthening the recipient's change talk (e.g., assertions about desire and commitment toward the target behavior) and softening the recipient's sustain talk (e.g., statements about barriers). MI clinicians achieve these goals using specific micro-skills (e.g., reflective listening) that reflect MI's fundamental spirits (i.e. collaboration, acceptance, compassion, evocation.
Treatment As UsualOther
TAU included the opportunity for mothers to meet with a NICU psychologist or psychology trainee at least once-per-week for supportive care.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Mothers in the MI-arm received up to six weekly MI sessions until the baby was discharged from the NICU. Mothers whose baby was discharged prior to or during week six completed measures at enrollment and NICU discharge. Mothers whose baby was discharged after week six completed questionnaires at enrollment and at the end of week six. Mothers could choose whether to complete MI in English or Spanish. Native Spanish-speaking, ethnically-matched providers conducted Spanish-language sessions. Study team members offered to read questionnaires aloud and record responses; however, all participants chose to independently complete paper-and-pencil measures. Receives: Behavioral: Motivational Interviewing |
| Treatment as Usual | Active comparator | In the institution in which the investigators conducted this study, per institutional standards, TAU included the opportunity for mothers to meet with a NICU psychologist or psychology trainee at least once-per-week for supportive care. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as assessed by >75% of MI-randomized mothers receiving at least one MI session
Feasibility as assessed by >75% of MI-randomized mothers receiving > one MI session
Measured: 3 years
Secondary outcomes (1)
Acceptability as assessed by the number of mothers' open to completing additional MI session/s
MI acceptable, as evidenced by mothers reporting willingness (yes/no) to receive a second MI session after completing their first MI session.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start2 Nov 2018
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Intensive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators used a randomized controlled trial (RCT) design and randomized consenting mothers (1:1) in blocks of 10 to the MI-arm or a treatment-as-usual (TAU) control-arm.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Faith, PhD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488196
- Sponsor's protocol ID
- IRB00182045
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Fidelity of Motivational Interviewing Targeting Ethnically-, Linguistically-, and Racially-diverse Mothers' Neonatal Intensive Care Unit (NICU) Bedside Presence
- ClinicalTrials.gov ID
- NCT06488196
- Acronym / sponsor ID
- IRB00182045
- Conditions
- Neonatal Intensive Care
- Keywords
- motivational interviewing, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Maternal presence in the NICU during an infant's hospitalization is critical for the infant's medical recovery and overall neurodevelopmental trajectory. However, despite the importance of maternal presence in these settings, the current literature shows that families are often absent at bedside. To date, no behavioral interventions have been conducted to promote increased maternal visitation patterns in NICU settings. This project will aim to fill this gap in the literature by conducting a pilot study that uses a motivational interviewing intervention with the aim of increasing maternal visitation rates to a level IV NICU.
Detailed description
This study will be conducted as a randomized controlled pilot trial of a motivational interviewing intervention. Mothers will be contacted for enrollment in the study within the first 48-72 hours of the infant's NICU admission. Contact with the mother will occur in-person within those first 48-72 hours of admission. If mother is unavailable in person within the first 72 hours, a telephone call will be made to her. Should the mother agree to participate in the study, written consent will be obtained if the meeting is taking place in person. If the first contact takes place via telephone, then verbal consent alone will be obtained at that time followed by written consent during the first in-person meeting with mother (see below for detailed consent procedures). Once enrolled, the mother will be assigned to one of two study arms - the treatment group or the treatment-as-usual (comparison) group. Mothers will not be provided with information about study arm assignment.
Cluster randomization: Group assignment will be determined by location of the infant in the NICU. The comparison group will be assigned to the North side of the unit while the treatment group will be assigned to the South side of the unit. Assignment to each side of the unit (i.e., North or South) is routinely determined based on census capacity/availability and not based on other factors that may inhibit the randomization process.
Both study groups will receive 6 sessions with the experimental group receiving motivation interviewing (MI) and the control group receiving support as usual. Additional supportive interventions will continue as needed and determined by the clinical needs and consistent with current treatment as usual (TAU). All families will also complete a discharge study visit within 7 days of NICU discharge; hence, participants will receive a total of at least 7 study visits throughout infant's hospitalization. The goal of the first session will be to establish rapport and obtain information about the sources of stress and distress to target in later sessions. Weekly follow-up visits with all families will continue utilization of supportive and problem-solving approaches to manage stressors identified in the initial session. If mothers cannot be reached in person for projected visits at various time points, attempts will be made to connect with mothers via telephone irrespective of study assignment.
More specifically, the first consultation will consist of a semi-structured clinical interview that will assess the following general topics: (1) family-reported psychosocial factors related to the perinatal period (i.e., antepartum, labor/delivery, postpartum, NICU hospitalization, possible NICU discharge periods); (2) perceptions of the caregiver-infant relationship; (3) family psychosocial stressors; (4) family adjustment to the NICU setting; (5) family self-report of coping; (6) family self-report of barriers to visiting the NICU.
All sessions will be audio-recorded in the treatment arm of the study while a portion of the sessions will be recorded in the comparison group (see data analysis section). All audiotaped sessions will be reviewed for fidelity to motivational interviewing treatment protocol by an MI-certified trainer for English sessions while the Spanish sessions will be reviewed by a doctoral-level graduate student with training in MI and under the supervision of the certified trainer reviewer.
However, if mother does not finish the questionnaires by the end of the visit/contact, she may be asked to stay longer at the unit or on the phone to complete the remaining questions. If she does not have time to complete the questions, the investigators will develop a plan for completing the remaining questions. For instance, the investigators may ask to contact her via phone within the next five days in order to read and complete the remaining questions or meet again during the next visit to the NICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators used a randomized controlled trial (RCT) design and randomized consenting mothers (1:1) in blocks of 10 to the MI-arm or a treatment-as-usual (TAU) control-arm.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingMothers in the MI-arm received up to six weekly MI sessions until the baby was discharged from the NICU. Mothers whose baby was discharged prior to or during week six completed measures at enrollment and NICU discharge. Mothers whose baby was discharged after week six completed questionnaires at enrollment and at the end of week six. Mothers could choose whether to complete MI in English or Spanish. Native Spanish-speaking, ethnically-matched providers conducted Spanish-language sessions. Study team members offered to read questionnaires aloud and record responses; however, all participants chose to independently complete paper-and-pencil measures. |
| Treatment as Usual | Active comparator | Other: Treatment As UsualIn the institution in which the investigators conducted this study, per institutional standards, TAU included the opportunity for mothers to meet with a NICU psychologist or psychology trainee at least once-per-week for supportive care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English- or Spanish-speaking mothers >18 years-old with a NICU-hospitalized infant
Key exclusion criteria (1 listed)
- Suicidality, cognitive disability preclude consent/participation, or psychotic/manic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational interviewing (MI) is a person-centered, goal-oriented psychotherapeutic intervention designed to enhance the recipient's motivation for and commitment to a target behavior or behavior change. MI's core action mechanisms include strengthening the recipient's change talk (e.g., assertions about desire and commitment toward the target behavior) and softening the recipient's sustain talk (e.g., statements about barriers). MI clinicians achieve these goals using specific micro-skills (e.g., reflective listening) that reflect MI's fundamental spirits (i.e. collaboration, acceptance, compassion, evocation. | Behavioural | Motivational Interviewing |
| Treatment As UsualTAU included the opportunity for mothers to meet with a NICU psychologist or psychology trainee at least once-per-week for supportive care. | Other | Treatment as Usual |
Primary outcome
Feasibility, as assessed by >75% of MI-randomized mothers receiving at least one MI session
Time frame: 3 years
Feasibility as assessed by >75% of MI-randomized mothers receiving > one MI session
1 secondary outcome
Acceptability as assessed by the number of mothers' open to completing additional MI session/s
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Faith, PhD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Treatment As Usual in people with Neonatal Intensive Care, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as assessed by >75% of MI-randomized mothers receiving at least one MI session (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.