Pre-TermNCT05282628
I-InTERACT Preterm
A study testing Building Better Brains and Behavior program (B4 Preterm) in people with Pre-Term, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later. Read more about this study
- Who is it for?
- Ages 36 to 96 months
- Conditions the study is for
- Pre-Term
- What is being tested?
- Building Better Brains and Behavior program (B4 Preterm)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Aug 2026
- 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 36 to 96 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age at enrollment: ages 3-8, inclusive
- Born at < 32 weeks gestational age
- Total T score of > 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of > 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale OR documented behavioral problems noted in medical chart and parent endorses current concerns about child's behaviors
- Language: English must be the primary spoken language in the home
Who cannot join
- Caregiver must be 18 years or older to participate in the intervention. Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings); English is not the primary language spoken in the home. Additionally, caregivers with a psychiatric hospitalization in the past year will be ineligible to participate. Children with certain types of metal in their heads will be unable to participate in the MRI portion but will be able to participate in the intervention and complete pre- and post-intervention questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.
Read the detailed description
The investigators will modify I-InTERACT North to reflect United States language and culture and emphasize our focus on neural plasticity and development. The modified intervention will be renamed Building Better Brains and Behavior (B4 Preterm). Then, investigators will conduct a single-arm clinical trial to establish B4 Preterm's feasibility, acceptability and preliminary efficacy in improving child and family outcomes. Additionally, neuroimaging (MRI/DTI) will be collected pre- and post-intervention. The primary neuroimaging sequence will allow the investigators to examine associations between white matter injury and treatment response as well as changes in neural activation and connectivity pre- to post-treatment. An exploratory neuroimaging sequence will also be collected pre- and post-intervention. This exploratory sequence will serve as a backup for the primary sequence in case it is affected by significant motion and allow the investigators to test this sequence in young children.
- Conditions
- Pre-Term
- Being tested
- Building Better Brains and Behavior program (B4 Preterm)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Better Brains and Behavior program (B4 Preterm)Behavioural
The program couples online learning modules with video conferencing sessions with a trained therapist to review skills and practice implementing the skills with live coaching. Online modules include didactic content, video clips of parents modeling the skills, and exercises. Parents will complete intervention modules sequentially in conjunction with scheduled 1:1 videoconference sessions with a trained therapist. Videoconference sessions with the therapist will be scheduled weekly, once parents have completed their modules. During these sessions, the therapist will review the online materials and provide active coaching to the parent on how to use the skills with their child (e.g., labeled praise, reflective responses). Each session follows a manualized therapy protocol to optimize content fidelity. Parents will be instructed to practice the parenting skills for 5 minutes each day to promote mastery in the home environment.
| Study group | Role | What they receive |
|---|---|---|
| Building Better Brains and Behavior program (B4 Preterm) | Experimental | Online learning modules completed sequentially and in conjunction with live coaching sessions led by a trained therapist. Receives: Behavioral: Building Better Brains and Behavior program (B4 Preterm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory (ECBI)
Child Behavior
Measured: Week 1
Eyberg Child Behavior Inventory (ECBI)
Child Behavior
Measured: Week 10
Child Behavior Checklist
Child Behavior
Measured: Week 1
Child Behavior Checklist
Child Behavior
Measured: Week 10
Behavior Rating Inventory of Executive Functions-2
Executive Function Behaviors
Measured: Week 1
Behavior Rating Inventory of Executive Functions-2
Executive Function Behaviors
Measured: Week 10
Center for Epidemiologic Studies Depression Scale (CES-D)
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Measured: Week 1
Center for Epidemiologic Studies Depression Scale (CES-D)
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Measured: Week 10
Adverse Childhood Experiences Scales (ACES)
Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.
Measured: Week 1
Adverse Childhood Experiences Scales (ACES)
Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.
Measured: Week 10
Pediatric Quality of Life Inventory (PedsQL)
Child functioning and quality of life
Measured: Week 1
Pediatric Quality of Life Inventory (PedsQL)
Child functioning and quality of life
Measured: Week 10
Dyadic Parent Child Interaction Coding System (DPICS)
Parenting Behaviors
Measured: Week 1
Dyadic Parent Child Interaction Coding System (DPICS)
Parenting Behaviors
Measured: Week 10
Satisfaction Survey
Satisfaction with Intervention
Measured: Week 10
Secondary outcomes (8)
Multi-shell diffusion sequence
Neuroimaging-MRI/DTI
Measured: Week 1
Multi-shell diffusion sequence
Neuroimaging-MRI/DTI
Measured: Week 10
3D-T1 weighted sequences
Neuroimaging-MRI/DTI
Measured: Week 1
3D-T1 weighted sequences
Neuroimaging-MRI/DTI
Measured: Week 10
3D T2- weighted sequence
Neuroimaging-MRI/DTI
Measured: Week 1
3D T2- weighted sequence
Neuroimaging-MRI/DTI
Measured: Week 10
Resting state fMRI sequence
Neuroimaging-MRI/DTI
Measured: Week 1
Resting state fMRI sequence
Neuroimaging-MRI/DTI
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Sep 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-TermStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari L Wade, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282628
- Sponsor's protocol ID
- 315361
- Status last verified
- Feb 2024
- First submitted
- 31 Aug 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Glazer S, McCullough K, Parikh NA, Barnes-Davis M, Yuan W, Dudley J, Williams T, Wade SL. [Formula: see text] Preliminary efficacy of a novel online parenting skills program for caregivers of preterm children with behavioral challenges. Child Neuropsychol. 2026 May;32(4):501-519. doi: 10.1080/09297049.2025.2579217. Epub 2025 Oct 31.
PubMed 41169198
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-InTERACT Preterm
- ClinicalTrials.gov ID
- NCT05282628
- Acronym / sponsor ID
- 315361
- Conditions
- Pre-Term
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 16 Mar 2022 (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.
Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.
Detailed description
The investigators will modify I-InTERACT North to reflect United States language and culture and emphasize our focus on neural plasticity and development. The modified intervention will be renamed Building Better Brains and Behavior (B4 Preterm). Then, investigators will conduct a single-arm clinical trial to establish B4 Preterm's feasibility, acceptability and preliminary efficacy in improving child and family outcomes. Additionally, neuroimaging (MRI/DTI) will be collected pre- and post-intervention. The primary neuroimaging sequence will allow the investigators to examine associations between white matter injury and treatment response as well as changes in neural activation and connectivity pre- to post-treatment. An exploratory neuroimaging sequence will also be collected pre- and post-intervention. This exploratory sequence will serve as a backup for the primary sequence in case it is affected by significant motion and allow the investigators to test this sequence in young children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Building Better Brains and Behavior program (B4 Preterm) | Experimental | Behavioral: Building Better Brains and Behavior program (B4 Preterm)Online learning modules completed sequentially and in conjunction with live coaching sessions led by a trained therapist. |
Who may qualify
- Ages
- 36 to 96 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age at enrollment: ages 3-8, inclusive
- Born at < 32 weeks gestational age
- Total T score of > 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of > 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale OR documented behavioral problems noted in medical chart and parent endorses current concerns about child's behaviors
- Language: English must be the primary spoken language in the home
Key exclusion criteria (1 listed)
- Caregiver must be 18 years or older to participate in the intervention. Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings); English is not the primary language spoken in the home. Additionally, caregivers with a psychiatric hospitalization in the past year will be ineligible to participate. Children with certain types of metal in their heads will be unable to participate in the MRI portion but will be able to participate in the intervention and complete pre- and post-intervention questionnaires.
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 |
|---|---|---|
| Building Better Brains and Behavior program (B4 Preterm)The program couples online learning modules with video conferencing sessions with a trained therapist to review skills and practice implementing the skills with live coaching. Online modules include didactic content, video clips of parents modeling the skills, and exercises. Parents will complete intervention modules sequentially in conjunction with scheduled 1:1 videoconference sessions with a trained therapist. Videoconference sessions with the therapist will be scheduled weekly, once parents have completed their modules. During these sessions, the therapist will review the online materials and provide active coaching to the parent on how to use the skills with their child (e.g., labeled praise, reflective responses). Each session follows a manualized therapy protocol to optimize content fidelity. Parents will be instructed to practice the parenting skills for 5 minutes each day to promote mastery in the home environment. | Behavioural | Building Better Brains and Behavior program (B4 Preterm) |
Primary outcome
Eyberg Child Behavior Inventory (ECBI)
Time frame: Week 1
Child Behavior
Eyberg Child Behavior Inventory (ECBI)
Time frame: Week 10
Child Behavior
Child Behavior Checklist
Time frame: Week 1
Child Behavior
Child Behavior Checklist
Time frame: Week 10
Child Behavior
Behavior Rating Inventory of Executive Functions-2
Time frame: Week 1
Executive Function Behaviors
Behavior Rating Inventory of Executive Functions-2
Time frame: Week 10
Executive Function Behaviors
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Week 1
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Week 10
Caregiver Depression; Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Adverse Childhood Experiences Scales (ACES)
Time frame: Week 1
Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.
Adverse Childhood Experiences Scales (ACES)
Time frame: Week 10
Caregiver Stress; Scores range from 0 to 10, with higher scores indicating a higher risks for developing later health problems.
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Week 1
Child functioning and quality of life
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Week 10
Child functioning and quality of life
Dyadic Parent Child Interaction Coding System (DPICS)
Time frame: Week 1
Parenting Behaviors
Dyadic Parent Child Interaction Coding System (DPICS)
Time frame: Week 10
Parenting Behaviors
Satisfaction Survey
Time frame: Week 10
Satisfaction with Intervention
8 secondary outcomes
Multi-shell diffusion sequence
Time frame: Week 1
Multi-shell diffusion sequence
Time frame: Week 10
3D-T1 weighted sequences
Time frame: Week 1
3D-T1 weighted sequences
Time frame: Week 10
3D T2- weighted sequence
Time frame: Week 1
3D T2- weighted sequence
Time frame: Week 10
Resting state fMRI sequence
Time frame: Week 1
Resting state fMRI sequence
Time frame: Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 41169198Glazer S, McCullough K, Parikh NA, Barnes-Davis M, Yuan W, Dudley J, Williams T, Wade SL. [Formula: see text] Preliminary efficacy of a novel online parenting skills program for caregivers of preterm children with behavioral challenges. Child Neuropsychol. 2026 May;32(4):501-519. doi: 10.1080/09297049.2025.2579217. Epub 2025 Oct 31.
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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.
Shari L Wade, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Better Brains and Behavior program (B4 Preterm) in people with Pre-Term, run by Children's Hospital Medical Center, Cincinnati 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 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 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?
Results are not available in the source record.
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?
Eyberg Child Behavior Inventory (ECBI) (time frame: Week 1). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282628, which also lists 1 linked publication.
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 6 Feb 2024.