ParentingPAPNCT05467371
Safe Babies: Parenting Action Plan ( PAP )
A study testing Parenting Action Plan and Safe Kids Home Safety Checklist in people with Parenting and Motivational Interviewing, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
Trial summary
The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. 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
- Parenting, Motivational Interviewing, Maltreatment/Abuse
- What is being tested?
- Parenting Action Plan and Safe Kids Home Safety Checklist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Aug 2022to 15 Jun 2025
- 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
- maternal caregivers of infant 2 months and younger
- can read and speak English or Spanish
- has zoom / teams / facetime / google hangout capability
Who cannot join
- infant is older than 2 months of age
- under 18 years of age
- no video/virtual capability
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor College of Medicine
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Texas Health Science Center at Tyler
Tyler, Texas, 75799
About this study
Official title: Safe Babies Parenting Action Plan RCT
The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby.
Read the detailed description
The purpose of this project is to evaluate whether prevention education using motivational interviewing focused on promoting positive maternal mental health, coping with inconsolable crying, life stress reduction, and positive coping strategies with difficult infant behavior can provide complimentary messaging that supports positive parental behavior and reduces risks associated with poor mental health and infant maltreatment. The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. It is delivered using motivational interviewing techniques. This study is not designed to develop education for "at-risk" individuals, rather the purpose is to develop a populationlevel prevention program.
- Conditions
- Parenting, Motivational Interviewing, Maltreatment/Abuse
- Being tested
- Parenting Action Plan, Safe Kids Home Safety Checklist
- Keywords
- parenting education, maternal mental health, infant maltreatment, motivational interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Action PlanBehavioural
The parenting action plan a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby.
Safe Kids Home Safety ChecklistBehavioural
Safe Kids created a home safety checklist to help keep kids safe, room by room.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Action Plan | Experimental | The parenting action plan is a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. Maternal caregivers will receive the booklet via mail and a trained research staff member will virtually go over the booklet using motivational interviewing strategies Receives: Behavioral: Parenting Action Plan |
| Safe Kids Home Safety Checklist | Active comparator | The Safe Kids Home Safety Checklist is a handout with information that focuses on home safety for parents of young children. Maternal caregivers will receive the handout via mail and a trained research staff member will virtually go over the handout with the parent using educational strategies. Receives: Behavioral: Safe Kids Home Safety Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Attributions change from 6 to 12 weeks post intervention
The Parent Attribution Test will be used to assess maltreatment risk. This survey was chosen because it has been shown to be predictive of maltreatment in high risk families27. Further, this survey is relatively immune to social desirability bias28, partially because it does not specifically ask parents about their own parenting practices.
Measured: 6 and 12 weeks post intervention
Parental competency change from 6 to 12 weeks post intervention
Parental competency will be measured using the Infant Characteristics Questionnaire29. The Infant Characteristics Questionnaire measures infant temperament. It is being included because difficult infants can impact how parents assess their own parental competency. Further, "difficult" infants are also at a higher risk for maltreatment. This measure will allow us to assess whether the PAP can help increase self-assessed competency, but also whether these self-assessed competencies increase for mothers who have infants that are more "difficult."
Measured: 6 and 12 weeks post intervention
Maternal depression change from 6 to 12 weeks post intervention
All women will be screened for depression using the Edinburg Postnatal Depression Scale34. It is important to clarify that the mothers will be screened for the study separate from the screening she will receive in the clinic. We will be assessing depression risk separately so that the medical record will not need to be used for research, nor will research information be used to inform medical decisions.
Measured: 6 and 12 weeks post intervention
Maternal bonding change from 6 to 12 weeks post intervention
This self-report measure assesses how the parent feels about their infant and is a proxy for bonding.
Measured: 6 and 12 weeks post intervention
Cognitive stimulation in the home change from 6 to 12 weeks post intervention
StimQ-I is a 43 point scale for measuring cognitive stimulation in the homes of infants ages 5 to 12 months. It is based on a questionnaire that is administered to the child's primary caregiver.
Measured: 6 and 12 weeks post intervention
Secondary outcomes (1)
Assess patient's Satisfaction level with the educational resource
Questionnaire developed to assess the parent's satisfaction with the resource
Measured: Immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start23 Aug 2022
- Primary completion1 May 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a randomized controlled trial with maternal caregivers of infants 2 months and younger. Maternal caregivers who consent to be in the study will be randomized into one of two groups. One group will get Safe Kids home safety education and the other group will receive the Parenting Action Plan with motivational interviewing techniques.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothy Mandell, The University of Texas Health Science Center, Houston
- Investigators
- Dorothy Mandell, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467371
- Sponsor's protocol ID
- HSC-SPH-23-1042
- Acronym
- PAP
- Status last verified
- Jun 2025
- First submitted
- 15 Jul 2022
- Last updated
- 27 Jun 2025
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Babies Parenting Action Plan RCT
- ClinicalTrials.gov ID
- NCT05467371
- Acronym / sponsor ID
- PAP / HSC-SPH-23-1042
- Conditions
- Parenting, Motivational Interviewing, Maltreatment/Abuse
- Keywords
- parenting education, maternal mental health, infant maltreatment, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 20 Jul 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.
The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby.
Detailed description
The purpose of this project is to evaluate whether prevention education using motivational interviewing focused on promoting positive maternal mental health, coping with inconsolable crying, life stress reduction, and positive coping strategies with difficult infant behavior can provide complimentary messaging that supports positive parental behavior and reduces risks associated with poor mental health and infant maltreatment. The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. It is delivered using motivational interviewing techniques. This study is not designed to develop education for "at-risk" individuals, rather the purpose is to develop a populationlevel prevention program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized controlled trial with maternal caregivers of infants 2 months and younger. Maternal caregivers who consent to be in the study will be randomized into one of two groups. One group will get Safe Kids home safety education and the other group will receive the Parenting Action Plan with motivational interviewing techniques.
| Arm | Type | Receives |
|---|---|---|
| Parenting Action Plan | Experimental | Behavioral: Parenting Action PlanThe parenting action plan is a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. Maternal caregivers will receive the booklet via mail and a trained research staff member will virtually go over the booklet using motivational interviewing strategies |
| Safe Kids Home Safety Checklist | Active comparator | Behavioral: Safe Kids Home Safety ChecklistThe Safe Kids Home Safety Checklist is a handout with information that focuses on home safety for parents of young children. Maternal caregivers will receive the handout via mail and a trained research staff member will virtually go over the handout with the parent using educational strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- maternal caregivers of infant 2 months and younger
- can read and speak English or Spanish
- has zoom / teams / facetime / google hangout capability
Key exclusion criteria (3 listed)
- infant is older than 2 months of age
- under 18 years of age
- no video/virtual capability
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 |
|---|---|---|
| Parenting Action PlanThe parenting action plan a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. | Behavioural | Parenting Action Plan |
| Safe Kids Home Safety ChecklistSafe Kids created a home safety checklist to help keep kids safe, room by room. | Behavioural | Safe Kids Home Safety Checklist |
Primary outcome
Parental Attributions change from 6 to 12 weeks post intervention
Time frame: 6 and 12 weeks post intervention
The Parent Attribution Test will be used to assess maltreatment risk. This survey was chosen because it has been shown to be predictive of maltreatment in high risk families27. Further, this survey is relatively immune to social desirability bias28, partially because it does not specifically ask parents about their own parenting practices.
Parental competency change from 6 to 12 weeks post intervention
Time frame: 6 and 12 weeks post intervention
Parental competency will be measured using the Infant Characteristics Questionnaire29. The Infant Characteristics Questionnaire measures infant temperament. It is being included because difficult infants can impact how parents assess their own parental competency. Further, "difficult" infants are also at a higher risk for maltreatment. This measure will allow us to assess whether the PAP can help increase self-assessed competency, but also whether these self-assessed competencies increase for mothers who have infants that are more "difficult."
Maternal depression change from 6 to 12 weeks post intervention
Time frame: 6 and 12 weeks post intervention
All women will be screened for depression using the Edinburg Postnatal Depression Scale34. It is important to clarify that the mothers will be screened for the study separate from the screening she will receive in the clinic. We will be assessing depression risk separately so that the medical record will not need to be used for research, nor will research information be used to inform medical decisions.
Maternal bonding change from 6 to 12 weeks post intervention
Time frame: 6 and 12 weeks post intervention
This self-report measure assesses how the parent feels about their infant and is a proxy for bonding.
Cognitive stimulation in the home change from 6 to 12 weeks post intervention
Time frame: 6 and 12 weeks post intervention
StimQ-I is a 43 point scale for measuring cognitive stimulation in the homes of infants ages 5 to 12 months. It is based on a questionnaire that is administered to the child's primary caregiver.
1 secondary outcome
Assess patient's Satisfaction level with the educational resource
Time frame: Immediately post intervention
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 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Parenting
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Active, not recruiting
CHOICES3: Sickle Cell Disease Parenting CHOICES
Sickle Cell Disease, Sickle Cell Trait
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Recruiting
Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study
Parenting Stress, Mental Health
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.
Dorothy Mandell, PhD principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Action Plan and Safe Kids Home Safety Checklist in people with Parenting and Motivational Interviewing, run by The University of Texas Health Science Center, Houston at 3 sites 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 3 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Parental Attributions change from 6 to 12 weeks post intervention (time frame: 6 and 12 weeks post intervention). The study lists 5 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 27 Jun 2025.