ParentingNCT02428465
Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of Life
A study testing Purposeful Parenting in people with Parenting, run by Boston Medical Center at 2 sites in United States.
Trial summary
Pediatricians' provision of parenting-focused anticipatory guidance often does not meet parents' needs; the few studies that have investigated primary-care based strategies to promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting their generalizability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Purposeful Parenting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2015to 1 Dec 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Families (parent >=18 years of age) with a newborn, born at >= 34 weeks, presenting for well-child care
- Family plans to remain at that practice
- English or Spanish speaking
Who cannot join
- Debilitating chronic condition; prematurity (<34 weeks gestation)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
Dimock Health Center
Roxbury, Massachusetts, 02119
About this study
Pediatricians' provision of parenting-focused anticipatory guidance often does not meet parents' needs; the few studies that have investigated primary-care based strategies to promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting their generalizability. Therefore, the Purposeful Parenting was developed as a universal program of enhanced anticipatory guidance. At each well-child visit in the first year of a child's life, Purposeful Parenting provides parents with: 1) scripted anticipatory guidance and handouts focused on the child's emerging social-emotional and linguistic (SEL) skills, brain development and the importance of responsive parenting; and 2) a "reminder" item (e.g., a "Smile at Me" onesie) that allows for in-office role modeling and promotes practicing of an age-specific, nurturing parent-child interaction. If an in-office intervention is missed (e.g. parent cancels visit, interventionist out sick) the intervention will be delivered by telephone if possible by the site-based clinical interventionists and the "reminder" items will be mailed.
Read the detailed description
The investigators will conduct a two-phase study. Phase I (months 1-4) will entail a brief pilot of Purposeful Parenting in three Boston-based health centers to optimize quality and logistical details. Phase II (months 5-36) will determine, with a parallel group randomized controlled trial (RCT), whether delivering Purposeful Parenting leads to increased responsive parenting at the intervention's conclusion (in intervention vs control parents), assessed using a validated observational measure. The investigators will enroll 260 low-income families with a full term newborn infant who present for well-child care. Families randomized to the control group will receive usual anticipatory guidance at each well-child visit in the first 12 months of life. Families randomized to the intervention group will receive usual anticipatory guidance plus Purposeful Parenting. As secondary outcomes, the investigators will explore the degree to which Purposeful Parenting (in intervention vs control parents) increases parental knowledge about responsive parenting and child development, reduces parenting stress and improves perceptions of parenting self-efficacy (via validated parental self-report measures) at the conclusion of the intervention. Investigators will explore potential differences by study group in child SEL development at the conclusion of the intervention. In addition, investigators will examine differences in the above listed outcomes are 6 months following the intervention. The RCT will include the collection of process level data including cost.
- Conditions
- Parenting
- Being tested
- Purposeful Parenting
- Keywords
- Purposeful Parenting, Parenting stress, Social-emotional and linguistic (SEL) skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purposeful ParentingBehavioural
Purposeful Parenting reinforces responsive interactions that help promote emerging developmental skills. This information is presented over the course of a child's first 12 months, such that core lessons are the same but specific skills are designed to be developmentally appropriate. This repetitiveness, along with the provision of age-appropriate behavioral guidance, will allow parents to successfully engage in responsive interactions with their children.
| Study group | Role | What they receive |
|---|---|---|
| Purposeful Parenting | Experimental | Families randomized to the intervention group will receive their pediatric provider's usual anticipatory guidance plus Purposeful Parenting. Receives: Behavioral: Purposeful Parenting |
| Control Group | No intervention | Families randomized to the control group will receive usual anticipatory guidance, delivered at the discretion of their pediatric provider, at each well-child visit in the first 12 months of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsive Parenting
Responsive parenting will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLOTM), which involves an observer watching a 10 minute videotaped interaction to assess interaction between a parent and her infant or toddler. The PICCOLO is well-validated with inter-rater reliability=0.77; scale reliability=0.78; content, construct and predictive validity are acceptable.
Measured: At intervention conclusion (child is 12 months)
Responsive Parenting
Responsive parenting will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLOTM), which involves an observer watching a 10 minute videotaped interaction to assess interaction between a parent and her infant or toddler. The PICCOLO is well-validated with inter-rater reliability=0.77; scale reliability=0.78; content, construct and predictive validity are acceptable.
Measured: 6 months post intervention (child is 18 months)
Secondary outcomes (3)
Parental knowledge of infant/toddler development, health and safety, and positive parenting practices
Parental knowledge of infant/toddler development, health and safety, and positive parenting practices will be assessed by the 75-item Knowledge of Infant Development (KIDI) scale. The scale was developed to be accessible to parents with limited literacy and to be culturally neutral. Cronbach's alpha for parents is 0.82; test-retest reliability for parents is 0.92; validity has also been deemed acceptable.
Measured: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Parenting stress
Parenting stress will be assessed by the 36-item short form of the Abidin's Parenting Stress Index (PSI), with subscales including perceptions of social isolation, attachment to the child and parental health. Cronbach's alpha is 0.91 for the total scale; six month test-retest coefficients are 0.68-0.85.
Measured: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Satisfaction and confidence in parenting skills
Satisfaction and confidence in parenting skills will be assessed by the 17-item Parenting Sense of Competency scale. Internal reliability is excellent, with Cronbach's alphas ranging from 0.75-0.88. Two sub-scales measure perceptions of efficacy and satisfaction in the parenting role.
Measured: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startNov 2015
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Responsible party
- Principal investigator, Megan Bair-Merritt, Boston Medical Center
- Investigators
- Megan H Bair-Merritt, MD, MSCE, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428465
- Sponsor's protocol ID
- H-33740
- Status last verified
- Dec 2018
- First submitted
- 8 Apr 2015
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c.
PubMed 23457149Magar NA, Dabova-Missova S, Gjerdingen DK. Effectiveness of targeted anticipatory guidance during well-child visits: a pilot trial. J Am Board Fam Med. 2006 Sep-Oct;19(5):450-8. doi: 10.3122/jabfm.19.5.450.
PubMed 16951294Olson LM, Inkelas M, Halfon N, Schuster MA, O'Connor KG, Mistry R. Overview of the content of health supervision for young children: reports from parents and pediatricians. Pediatrics. 2004 Jun;113(6 Suppl):1907-16.
PubMed 15173461Cook GA, Innocenti MS, Roggman LA, Jump Norman VK. PICCOLO: A simple parent-child interaction measure and its use in early intervention. New York, 2011.
Kruizinga I, Jansen W, Mieloo CL, Carter AS, Raat H. Screening accuracy and clinical application of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA). PLoS One. 2013 Aug 30;8(8):e72602. doi: 10.1371/journal.pone.0072602. eCollection 2013.
PubMed 24023626Rescorla L, Alley A. Validation of the language development survey (LDS): a parent report tool for identifying language delay in toddlers. J Speech Lang Hear Res. 2001 Apr;44(2):434-45. doi: 10.1044/1092-4388(2001/035).
PubMed 11324663MacPhee D. Knowledge of infant development inventory. Chapel Hill, NC: University of North Carolina; 1981.
Abidin R. Parenting Stress Index: Professional Manual. 3rd ed. Odessa, FL: Psychological Assessment Resources; 1995.
Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.
PubMed 18991983
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of Life
- ClinicalTrials.gov ID
- NCT02428465
- Acronym / sponsor ID
- H-33740
- Conditions
- Parenting
- Keywords
- Purposeful Parenting, Parenting stress, Social-emotional and linguistic (SEL) skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Nov 2015
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 28 Apr 2015 (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.
Pediatricians' provision of parenting-focused anticipatory guidance often does not meet parents' needs; the few studies that have investigated primary-care based strategies to promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting their generalizability. Therefore, the Purposeful Parenting was developed as a universal program of enhanced anticipatory guidance. At each well-child visit in the first year of a child's life, Purposeful Parenting provides parents with: 1) scripted anticipatory guidance and handouts focused on the child's emerging social-emotional and linguistic (SEL) skills, brain development and the importance of responsive parenting; and 2) a "reminder" item (e.g., a "Smile at Me" onesie) that allows for in-office role modeling and promotes practicing of an age-specific, nurturing parent-child interaction. If an in-office intervention is missed (e.g. parent cancels visit, interventionist out sick) the intervention will be delivered by telephone if possible by the site-based clinical interventionists and the "reminder" items will be mailed.
Detailed description
The investigators will conduct a two-phase study. Phase I (months 1-4) will entail a brief pilot of Purposeful Parenting in three Boston-based health centers to optimize quality and logistical details. Phase II (months 5-36) will determine, with a parallel group randomized controlled trial (RCT), whether delivering Purposeful Parenting leads to increased responsive parenting at the intervention's conclusion (in intervention vs control parents), assessed using a validated observational measure. The investigators will enroll 260 low-income families with a full term newborn infant who present for well-child care. Families randomized to the control group will receive usual anticipatory guidance at each well-child visit in the first 12 months of life. Families randomized to the intervention group will receive usual anticipatory guidance plus Purposeful Parenting. As secondary outcomes, the investigators will explore the degree to which Purposeful Parenting (in intervention vs control parents) increases parental knowledge about responsive parenting and child development, reduces parenting stress and improves perceptions of parenting self-efficacy (via validated parental self-report measures) at the conclusion of the intervention. Investigators will explore potential differences by study group in child SEL development at the conclusion of the intervention. In addition, investigators will examine differences in the above listed outcomes are 6 months following the intervention. The RCT will include the collection of process level data including cost.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purposeful Parenting | Experimental | Behavioral: Purposeful ParentingFamilies randomized to the intervention group will receive their pediatric provider's usual anticipatory guidance plus Purposeful Parenting. |
| Control Group | No intervention | –Families randomized to the control group will receive usual anticipatory guidance, delivered at the discretion of their pediatric provider, at each well-child visit in the first 12 months of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Families (parent >=18 years of age) with a newborn, born at >= 34 weeks, presenting for well-child care
- Family plans to remain at that practice
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Debilitating chronic condition; prematurity (<34 weeks gestation)
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 |
|---|---|---|
| Purposeful ParentingPurposeful Parenting reinforces responsive interactions that help promote emerging developmental skills. This information is presented over the course of a child's first 12 months, such that core lessons are the same but specific skills are designed to be developmentally appropriate. This repetitiveness, along with the provision of age-appropriate behavioral guidance, will allow parents to successfully engage in responsive interactions with their children. | Behavioural | Purposeful Parenting |
Primary outcome
Responsive Parenting
Time frame: At intervention conclusion (child is 12 months)
Responsive parenting will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLOTM), which involves an observer watching a 10 minute videotaped interaction to assess interaction between a parent and her infant or toddler. The PICCOLO is well-validated with inter-rater reliability=0.77; scale reliability=0.78; content, construct and predictive validity are acceptable.
Responsive Parenting
Time frame: 6 months post intervention (child is 18 months)
Responsive parenting will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLOTM), which involves an observer watching a 10 minute videotaped interaction to assess interaction between a parent and her infant or toddler. The PICCOLO is well-validated with inter-rater reliability=0.77; scale reliability=0.78; content, construct and predictive validity are acceptable.
3 secondary outcomes
Parental knowledge of infant/toddler development, health and safety, and positive parenting practices
Time frame: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Parenting stress
Time frame: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Satisfaction and confidence in parenting skills
Time frame: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
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 28 Dec 2018.
- Background: PubMed 23457149Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c.
- Background: PubMed 16951294Magar NA, Dabova-Missova S, Gjerdingen DK. Effectiveness of targeted anticipatory guidance during well-child visits: a pilot trial. J Am Board Fam Med. 2006 Sep-Oct;19(5):450-8. doi: 10.3122/jabfm.19.5.450.
- Background: PubMed 15173461Olson LM, Inkelas M, Halfon N, Schuster MA, O'Connor KG, Mistry R. Overview of the content of health supervision for young children: reports from parents and pediatricians. Pediatrics. 2004 Jun;113(6 Suppl):1907-16.
- BackgroundCook GA, Innocenti MS, Roggman LA, Jump Norman VK. PICCOLO: A simple parent-child interaction measure and its use in early intervention. New York, 2011.
- Background: PubMed 24023626Kruizinga I, Jansen W, Mieloo CL, Carter AS, Raat H. Screening accuracy and clinical application of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA). PLoS One. 2013 Aug 30;8(8):e72602. doi: 10.1371/journal.pone.0072602. eCollection 2013.
- Background: PubMed 11324663Rescorla L, Alley A. Validation of the language development survey (LDS): a parent report tool for identifying language delay in toddlers. J Speech Lang Hear Res. 2001 Apr;44(2):434-45. doi: 10.1044/1092-4388(2001/035).
- BackgroundMacPhee D. Knowledge of infant development inventory. Chapel Hill, NC: University of North Carolina; 1981.
- BackgroundAbidin R. Parenting Stress Index: Professional Manual. 3rd ed. Odessa, FL: Psychological Assessment Resources; 1995.
- Background: PubMed 18991983Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.
- Individual participant dataSharing planned: No
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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.
Megan H Bair-Merritt, MD, MSCE principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purposeful Parenting in people with Parenting, run by Boston Medical Center at 2 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 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 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Responsive Parenting (time frame: At intervention conclusion (child is 12 months)). 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 NCT02428465, which also lists 9 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 28 Dec 2018.