Child Behavior ProblemI2P-RCTNCT06767293
I-InTERACT Preterm Parenting
A study testing I-InTERACT Parenting Intervention (I2P) and coaching sessions, I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions and Internet Resources in people with Child Behavior Problem and Preterm, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Problem, Preterm, Parent-Child Relations
- What is being tested?
- I-InTERACT Parenting Intervention (I2P) and coaching sessions, I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions and Internet Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- English is the primary spoken language in the home.
Who cannot join
- Is not 18 years or older.
- 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.
- Caregivers with a psychiatric hospitalization in the past year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Shari Wade, PhD, 5138034737, shari.wade@cchmc.org
Kaylen McCullough, BS, 8595336164, kaylen.mccullough@cchmc.org
About this study
Official title: I-InTERACT Preterm Parenting Randomized Controlled Trial
Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.
Read the detailed description
Many children born very preterm or extremely preterm exhibit a distinct behavioral phenotype characterized by impairments in cognition and attention and concomitant social and emotional problems. These children are significantly more likely to develop ADHD than children born at term and have similar rates of comorbid symptoms such as noncompliance, emotionality, and attention-seeking behaviors as those observed in children with ADHD. Although addressing children's mental health and behavioral challenges is a priority identified by parents, evidence-based interventions to promote effective parenting and mitigate child behavior problems in this population are lacking.
From 2021-2022, a single-arm pilot clinical trial was conducted for children born very preterm using content adapted from previous trials of I-InTERACT North and I-InTERACT Express, which included seven sessions and weekly online coaching from a therapist. Children demonstrated a significant reduction in externalizing behavior problems from pre- to post-intervention, and caregivers' positive parenting skills significantly increased during the same period.
Given relatively high rates of attrition in the pilot trial and stakeholder feedback regarding challenges in completing the program, the utility of microlearning delivery-delivering content in approximately 5-minute segments-will be tested relative to the existing I-InTERACT Preterm program and an internet resource comparison group. This approach is anticipated to improve uptake, engagement, and retention, particularly for young adults who routinely consume information in this format, while maintaining the efficacy of the original program.
A three-arm randomized controlled trial (RCT) is proposed to compare the seven-session I2P program to the microlearning delivery mode (I2P-Micro) and an internet resource comparison group (IRC). Participants in the I2P and I2P-Micro groups will also meet weekly or biweekly with a trained therapist to review content and receive coaching while practicing skills. Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.
- Conditions
- Child Behavior Problem, Preterm, Parent-Child Relations, Parenting
- Being tested
- I-InTERACT Parenting Intervention (I2P) and coaching sessions, I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions, Internet Resources
- Keywords
- telehealth, online learning, microlearning
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-InTERACT Parenting Intervention (I2P) and coaching sessionsBehavioural
Online learning sessions for parents of preterm children
I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessionsBehavioural
Online microlearning sessions for parents of preterm children
Internet ResourcesOther
control condition
| Study group | Role | What they receive |
|---|---|---|
| I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching | Active comparator | Not described Receives: Behavioral: I-InTERACT Parenting Intervention (I2P) and coaching sessions |
| I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching | Active comparator | Not described Receives: Behavioral: I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions |
| Internet Resource Group | Other | Control condition Receives: Other: Internet Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score
Minimum score is 0, maximum score is not applicable as parents may exhibit any number of positive behaviors during the time frame data is collected. A higher score means a greater number of positive parenting behaviors were exhibited, which is considered better.
Measured: 3 months post baseline and 6 months post baseline
Child Behavior Checklist Externalizing T-score
Minimum t score for girls is 33, and maximum t score is 100. Minimum t score for boys is 34 and maximum t score is 100. A higher t score indicates more externalizing behaviors, which is considered worse.
Measured: 3 months post baseline and 6 months post baseline
Secondary outcomes (3)
ECBI Intensity T-Score
The ECBI Problem T-Score is a 36-item checklist of concerns (e.g., noncompliance, emotionality, attention-seeking) will be used to assess the number and intensity of child behavior problems pre- and post-treatment. On the ECBI, the parent rates how often each behavior occurs (7-point intensity scale), and whether the behavior is a problem (Yes/No Problem Scale). Higher T-Scores indicate greater intensity of problem behaviors. The lowest T-Score is 36 and the highest is 252, with a clinical cut-off at 60. During screening for this study, a T-Score greater than 55 for this scale meets meeting eligibility criteria.
Measured: 3 months post baseline and 6 months post baseline
ECBI Problem T-Score
The ECBI Problem T-Score is a 36-item checklist of concerns (e.g., noncompliance, emotionality, attention-seeking) will be used to assess the number and intensity of child behavior problems pre- and post-treatment. On the ECBI, the parent rates how often each behavior occurs (7-point intensity scale), and whether the behavior is a problem (Yes/No Problem Scale). Higher T-Scores indicate more challenging behaviors. The lowest T-Score is 41 and the highest is 88, with a clinical cut-off at 60. During screening for this study, a T-Score greater than 55 for this scale meets meeting eligibility criteria.
Measured: 3 months post baseline and 6 months post baseline
Caregiver Psychological Distress
Caregiver psychological distress will be assessed using the CES-D, a 20-item self-report inventory in which participants rate how often over the last week they have been bothered by various symptoms of depression in the last week. Total scores range from 0 to 60, with higher scores indicate greater caregiver distress. Scores 16 and above indicate a risk for clinical depression.
Measured: 3 months post baseline and 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start27 Nov 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Child Behavior ProblemStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Wade, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767293
- Sponsor's protocol ID
- 2024-0349
- Acronym
- I2P-RCT
- Status last verified
- Feb 2026
- First submitted
- 12 Nov 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified data will be shared.
Publications
Ask H, Gustavson K, Ystrom E, Havdahl KA, Tesli M, Askeland RB, Reichborn-Kjennerud T. Association of Gestational Age at Birth With Symptoms of Attention-Deficit/Hyperactivity Disorder in Children. JAMA Pediatr. 2018 Aug 1;172(8):749-756. doi: 10.1001/jamapediatrics.2018.1315.
PubMed 29946656de Silva A, Neel ML, Maitre N, Busch T, Taylor HG. Resilience and vulnerability in very preterm 4-year-olds. Clin Neuropsychol. 2021 Jul;35(5):904-924. doi: 10.1080/13854046.2020.1817565. Epub 2020 Sep 13.
PubMed 32924801Jones K, Daley D, Hutchings J, Bywater T, Eames C. Efficacy of the Incredible Years Programme as an early intervention for children with conduct problems and ADHD: long-term follow-up. Child Care Health Dev. 2008 May;34(3):380-90. doi: 10.1111/j.1365-2214.2008.00817.x.
PubMed 18410644Williams TS, McDonald KP, Roberts SD, Westmacott R, Dlamini N, Tam EWY. Understanding Early Childhood Resilience Following Neonatal Brain Injury From Parents' Perspectives Using a Mixed-Method Design. J Int Neuropsychol Soc. 2019 Apr;25(4):390-402. doi: 10.1017/S1355617719000079.
PubMed 31050330Wang C, Bakhet M, Roberts D, Gnani S, El-Osta A. The efficacy of microlearning in improving self-care capability: a systematic review of the literature. Public Health. 2020 Sep;186:286-296. doi: 10.1016/j.puhe.2020.07.007. Epub 2020 Aug 31.
PubMed 32882481De Gagne JC, Woodward A, Park HK, Sun H, Yamane SS. Microlearning in health professions education: a scoping review protocol. JBI Database System Rev Implement Rep. 2019 Jun;17(6):1018-1025. doi: 10.11124/JBISRIR-2017-003884.
PubMed 30489350
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-InTERACT Preterm Parenting Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06767293
- Acronym / sponsor ID
- I2P-RCT / 2024-0349
- Conditions
- Child Behavior Problem, Preterm, Parent-Child Relations, Parenting
- Keywords
- telehealth, online learning, microlearning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Jan 2025 (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.
Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.
Detailed description
Many children born very preterm or extremely preterm exhibit a distinct behavioral phenotype characterized by impairments in cognition and attention and concomitant social and emotional problems. These children are significantly more likely to develop ADHD than children born at term and have similar rates of comorbid symptoms such as noncompliance, emotionality, and attention-seeking behaviors as those observed in children with ADHD. Although addressing children's mental health and behavioral challenges is a priority identified by parents, evidence-based interventions to promote effective parenting and mitigate child behavior problems in this population are lacking.
From 2021-2022, a single-arm pilot clinical trial was conducted for children born very preterm using content adapted from previous trials of I-InTERACT North and I-InTERACT Express, which included seven sessions and weekly online coaching from a therapist. Children demonstrated a significant reduction in externalizing behavior problems from pre- to post-intervention, and caregivers' positive parenting skills significantly increased during the same period.
Given relatively high rates of attrition in the pilot trial and stakeholder feedback regarding challenges in completing the program, the utility of microlearning delivery-delivering content in approximately 5-minute segments-will be tested relative to the existing I-InTERACT Preterm program and an internet resource comparison group. This approach is anticipated to improve uptake, engagement, and retention, particularly for young adults who routinely consume information in this format, while maintaining the efficacy of the original program.
A three-arm randomized controlled trial (RCT) is proposed to compare the seven-session I2P program to the microlearning delivery mode (I2P-Micro) and an internet resource comparison group (IRC). Participants in the I2P and I2P-Micro groups will also meet weekly or biweekly with a trained therapist to review content and receive coaching while practicing skills. Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching | Active comparator | Behavioral: I-InTERACT Parenting Intervention (I2P) and coaching sessions |
| I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching | Active comparator | Behavioral: I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions |
| Internet Resource Group | Other | Other: Internet ResourcesControl condition |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
- English is the primary spoken language in the home.
Key exclusion criteria (4 listed)
- Is not 18 years or older.
- 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.
- Caregivers with a psychiatric hospitalization in the past year.
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 |
|---|---|---|
| I-InTERACT Parenting Intervention (I2P) and coaching sessionsOnline learning sessions for parents of preterm children | Behavioural | I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching |
| I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessionsOnline microlearning sessions for parents of preterm children | Behavioural | I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching |
| Internet Resourcescontrol condition | Other | Internet Resource Group |
Primary outcome
Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score
Time frame: 3 months post baseline and 6 months post baseline
Minimum score is 0, maximum score is not applicable as parents may exhibit any number of positive behaviors during the time frame data is collected. A higher score means a greater number of positive parenting behaviors were exhibited, which is considered better.
Child Behavior Checklist Externalizing T-score
Time frame: 3 months post baseline and 6 months post baseline
Minimum t score for girls is 33, and maximum t score is 100. Minimum t score for boys is 34 and maximum t score is 100. A higher t score indicates more externalizing behaviors, which is considered worse.
3 secondary outcomes
ECBI Intensity T-Score
Time frame: 3 months post baseline and 6 months post baseline
ECBI Problem T-Score
Time frame: 3 months post baseline and 6 months post baseline
Caregiver Psychological Distress
Time frame: 3 months post baseline and 6 months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 29946656Ask H, Gustavson K, Ystrom E, Havdahl KA, Tesli M, Askeland RB, Reichborn-Kjennerud T. Association of Gestational Age at Birth With Symptoms of Attention-Deficit/Hyperactivity Disorder in Children. JAMA Pediatr. 2018 Aug 1;172(8):749-756. doi: 10.1001/jamapediatrics.2018.1315.
- Background: PubMed 32924801de Silva A, Neel ML, Maitre N, Busch T, Taylor HG. Resilience and vulnerability in very preterm 4-year-olds. Clin Neuropsychol. 2021 Jul;35(5):904-924. doi: 10.1080/13854046.2020.1817565. Epub 2020 Sep 13.
- Background: PubMed 18410644Jones K, Daley D, Hutchings J, Bywater T, Eames C. Efficacy of the Incredible Years Programme as an early intervention for children with conduct problems and ADHD: long-term follow-up. Child Care Health Dev. 2008 May;34(3):380-90. doi: 10.1111/j.1365-2214.2008.00817.x.
- Background: PubMed 31050330Williams TS, McDonald KP, Roberts SD, Westmacott R, Dlamini N, Tam EWY. Understanding Early Childhood Resilience Following Neonatal Brain Injury From Parents' Perspectives Using a Mixed-Method Design. J Int Neuropsychol Soc. 2019 Apr;25(4):390-402. doi: 10.1017/S1355617719000079.
- Background: PubMed 32882481Wang C, Bakhet M, Roberts D, Gnani S, El-Osta A. The efficacy of microlearning in improving self-care capability: a systematic review of the literature. Public Health. 2020 Sep;186:286-296. doi: 10.1016/j.puhe.2020.07.007. Epub 2020 Aug 31.
- Background: PubMed 30489350De Gagne JC, Woodward A, Park HK, Sun H, Yamane SS. Microlearning in health professions education: a scoping review protocol. JBI Database System Rev Implement Rep. 2019 Jun;17(6):1018-1025. doi: 10.11124/JBISRIR-2017-003884.
- Individual participant dataSharing planned: No. Only de-identified data will be shared.
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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.
Shari 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 I-InTERACT Parenting Intervention (I2P) and coaching sessions, I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions and Internet Resources in people with Child Behavior Problem and Preterm, 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shari Wade, PhD (5134610952, shari.wade@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyadic Parent-Child Interaction Coding System Total Positive Parenting Behavior Score (time frame: 3 months post baseline and 6 months post baseline). The study lists 2 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 NCT06767293, which also lists 6 linked publications.
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 9 Feb 2026.