Infant ColicUTHealth THBNCT01217658
Measuring and Reducing Excessive Infant Crying
A study testing The Happiest Baby on The Block and AAP Infant Colic counseling in people with Infant Colic and Postpartum Depression, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp. The investigators will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the… Read more about this study
- Who is it for?
- Ages 3 to 5 weeks
- Conditions the study is for
- Infant Colic, Postpartum Depression
- What is being tested?
- The Happiest Baby on The Block and AAP Infant Colic counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2015
- 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 3 to 5 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- term, singleton neonates
- otherwise healthy
- parent must have at least a 6th grade understanding of English or Spanish
- infant must have colic (greater than 3 hours of crying per day)
- OR the infant's crying causes excessive stress on the either parent
Who cannot join
- cannot have a condition which would reasonably impact alertness or behavior
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Measuring and Reducing Excessive Infant Crying: A Randomized Trial
Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp. The investigators will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.
Read the detailed description
Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, \& depression assessed in the home by a masked nurse at 8 wks.
Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant \& maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).
- Conditions
- Infant Colic, Postpartum Depression
- Being tested
- The Happiest Baby on The Block, AAP Infant Colic counseling
- Keywords
- Randomized Trial, Infant Colic, Abusive Head Trauma, Shaken Baby Syndrome
- Medical subject headings
- Colic, Depression, Postpartum, Shaken Baby Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Happiest Baby on The BlockBehavioural
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
AAP Infant Colic counselingBehavioural
Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
| Study group | Role | What they receive |
|---|---|---|
| The Happiest Baby on The Block | Experimental | Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block". Receives: Behavioral: The Happiest Baby on The Block |
| AAP Education | Active comparator | Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling). Receives: Behavioral: AAP Infant Colic counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean night-time crying
Objectively recording night-time duration of excessive crying
Measured: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Mean sleep duration
objectively measuring infant sleep duration
Measured: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Secondary outcomes (2)
Maternal Depression, Anxiety and Somatization
Using the BSI-18 at study enrollment and conclusion.
Measured: At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Salivary Biomarkers
We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)
Measured: At Study Entry and at 2 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ColicStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Christopher Greeley, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217658
- Sponsor's protocol ID
- HSC-MS-10-0392
- Other IDs
- K23HD065872
- Acronym
- UTHealth THB
- Status last verified
- Dec 2015
- First submitted
- 6 Oct 2010
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring and Reducing Excessive Infant Crying: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01217658
- Acronym / sponsor ID
- UTHealth THB / HSC-MS-10-0392
- Conditions
- Infant Colic, Postpartum Depression
- Keywords
- Randomized Trial, Infant Colic, Abusive Head Trauma, Shaken Baby Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Oct 2010 (estimated)
- 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.
Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp. The investigators will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.
Detailed description
Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, \& depression assessed in the home by a masked nurse at 8 wks.
Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant \& maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Happiest Baby on The Block | Experimental | Behavioral: The Happiest Baby on The BlockThose receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block". |
| AAP Education | Active comparator | Behavioral: AAP Infant Colic counselingThose receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling). |
Who may qualify
- Ages
- 3 to 5 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- term, singleton neonates
- otherwise healthy
- parent must have at least a 6th grade understanding of English or Spanish
- infant must have colic (greater than 3 hours of crying per day)
- OR the infant's crying causes excessive stress on the either parent
Key exclusion criteria (1 listed)
- cannot have a condition which would reasonably impact alertness or behavior
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 |
|---|---|---|
| The Happiest Baby on The BlockThose receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block". | Behavioural | The Happiest Baby on The Block |
| AAP Infant Colic counselingThose receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic. | Behavioural | AAP Education |
Primary outcome
Mean night-time crying
Time frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Objectively recording night-time duration of excessive crying
Mean sleep duration
Time frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
objectively measuring infant sleep duration
2 secondary outcomes
Maternal Depression, Anxiety and Somatization
Time frame: At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Salivary Biomarkers
Time frame: At Study Entry and at 2 weeks after enrollment
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 Dec 2015.
- American Academy of Pediatrics Infant Colic WebsiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Happiest Baby on The Block and AAP Infant Colic counseling in people with Infant Colic and Postpartum Depression, run by The University of Texas Health Science Center, Houston 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 5 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 Dec 2015. 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?
Mean night-time crying (time frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.). 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?
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 Dec 2015.