I-InTERACT Preterm Parenting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorChildren's Hospital Medical Center, Cincinnati
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
I-InTERACT Parenting Intervention (I2P) and coaching sessions
BehavioralOnline learning sessions for parents of preterm children
I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions
BehavioralOnline microlearning sessions for parents of preterm children
Internet Resources
Other interventioncontrol condition
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: I-InTERACT Intervention (I2P) with regularly scheduled therapist coachingActive comparator 1 intervention
Group B: I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coachingActive comparator 1 intervention
Group C: Internet Resource GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months post baseline and 6 months post baseline2
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.
Time frame
3 months post baseline and 6 months post baselineSecondary outcomes
1
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.
Time frame
3 months post baseline and 6 months post baseline2
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.
Time frame
3 months post baseline and 6 months post baseline3
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.
Time frame
3 months post baseline and 6 months post baselineOther outcomes
1
Parental Stress
The Parental Stress Scale attempts to measure the levels of stress experienced by parents through an 18-item self-report measure. Questions are answered on a 5-Point Likert scale. Higher scores indicate a higher level of parental stress. There are no clinical cut-offs.
Time frame
3 months post baseline and 6 months post baseline2
Positive Attitude Towards Child
Positive attitude towards the child will be measured using the Five-Minute Speech Sample (FMSS), which is a procedure designed to assess expressed emotion in caregivers by asking respondents to talk for five uninterrupted minutes about their thoughts and feelings about a subject and how they get along together. The speech sample is coded, with a greater number of positive responses coded indicating a greater positive attitude towards their child.
Time frame
3 months post baseline and 6 months post baselineSponsors and contacts
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Source ClinicalTrials.gov