Parent-child InteractionFPT PFRNCT02139332
A Primary Prevention Trial to Strengthen Child Attachment in a Native Community
A study testing PFR Group and Resource & Referral Group in people with Parent-child Interaction, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Health Promotion program, and to assess the efficacy of the method in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parent-child Interaction
- What is being tested?
- PFR Group and Resource & Referral Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 30 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary caregiver for a child aged 10 to 30 months
- Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
- Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
- Caregiver has telephone access
- Caregiver is willing to have researchers come to their house
- Caregiver is English speaking
- Caregiver is willing to participate in a home-visiting program which includes video-recorded sessions of caregivers and their children playing
Who cannot join
- Hospitalized or imprisoned
- Living in a Treatment facility or shelter
- Unable to give consent
- Live in a household that already has a dyad enrolled in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Health Promotion program, and to assess the efficacy of the method in this community.
- Conditions
- Parent-child Interaction
- Being tested
- PFR Group, Resource & Referral Group
- Keywords
- Attachment theory, Parent- child relationship, Child mental health, Behavioral health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFR GroupBehavioural
The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session begins with a brief discussion and education on the target topic for that week . Then 20 minutes is spent on video recording a structured interaction between the caregiver and child or viewing the previous session's recording and engaging in reflective discussion about successful caregiving strategies and child's response to caregiver behavior (alternating weeks). Trained PFR specialists who are community members use the 5 "consultation strategies," labeled Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts.
Resource & Referral GroupBehavioural
The Resource \& Referral program consists of 1) an initial needs assessment to determine if the enrolled family has any unmet needs (housing, financial, health, mental health, etc…), 2) a tailored resource and referral packet will be mailed to the participant with the most important referrals marked, 3) a follow-up call will be made two weeks after mailing the packet to verify that the participant has received it, and 4) a second follow-up call will be made three months after the initial session, to assess types of services actually received, barriers to receiving services, and reassessing resources needed and providing additional referrals if needed.
| Study group | Role | What they receive |
|---|---|---|
| Resource & Referral group | Active comparator | Individuals randomized to the control group will receive a resource \& Referral service immediately after their baseline research visit. Receives: Behavioral: Resource & Referral Group |
| PFR Group | Experimental | Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment. Receives: Behavioral: PFR Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months
We are using the Nursing Child Assessment Satellite Training Teaching Scales to assess quality of caregiver-child interactions. Caregivers select an activity that their child cannot perform, such as drawing, and spend up to 5 minutes teaching this activity to the child. The interaction is video-recorded and coded for the caregiver's sensitivity to cues, response to distress, and fostering of social, emotional, and cognitive growth, as well as for the child's clarity of cues and responsiveness to the caregiver.
Measured: Baseline, 3-month and 6-month follow-ups
Secondary outcomes (3)
Change in Caregiver helplessness from baseline at 3 months and 6 months
Caregiver helplessness is measured by the Caregiving Helplessness Questionnaire, comprising 45 items specific to interactions with the child. We evaluate 2 subscales for this study: Mother-Child Frightened and Mother Helplessness ("mother" is changed to "caregiver")
Measured: Baseline, 3-month and 6-month follow-ups
Change in Caregiver stress from baseline at 3 months and 6 months
Caregiver stress is measured by the Parenting Stress Index/Short Form, a 36-item questionnaire with 3 subscales: caregiver distress, caregiver-child dysfunctional interaction, and difficult child.
Measured: Baseline, 3-month and 6-month follow-ups
Change in Child Social-emotional Competence from baseline at 3 months and 6 months
Children's social-emotional competencies are measured with the Infant-Toddler Social Emotional Assessment, a caregiver-report questionnaire
Measured: Baseline, 3-month and 6-month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJun 2015
- Primary completionMar 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parent-child InteractionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Cathryn Booth-LaForce, University of Washington
- Investigators
- Cathryn Booth-LaForce, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139332
- Sponsor's protocol ID
- STUDY00010153
- Other IDs
- 5R01NR014153-05
- Acronym
- FPT PFR
- Status last verified
- Aug 2021
- First submitted
- 13 May 2014
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Oxford M, Booth-LaForce C, Echo-Hawk A, Madesclaire O, Parrish L, Widner M, Petras A, Abrahamson-Richards T, Nelson K, Buchwald D; CATCH Project Team. Promoting First Relationships(R): Implementing a Home Visiting Research Program in Two American Indian Communities. Can J Nurs Res. 2020 Jun;52(2):149-156. doi: 10.1177/0844562120914424. Epub 2020 Mar 26.
PubMed 32216455Booth-LaForce C, Oxford ML, O'Leary R, Rees J, Petras A, Buchwald DS. Implementation fidelity of the Promoting First Relationships intervention program in a Native community. Transl Behav Med. 2023 Jan 20;13(1):34-41. doi: 10.1093/tbm/ibac060.
PubMed 36227860
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Primary Prevention Trial to Strengthen Child Attachment in a Native Community
- ClinicalTrials.gov ID
- NCT02139332
- Acronym / sponsor ID
- FPT PFR / STUDY00010153
- Conditions
- Parent-child Interaction
- Keywords
- Attachment theory, Parent- child relationship, Child mental health, Behavioral health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 May 2014 (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.
The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Health Promotion program, and to assess the efficacy of the method in this community.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resource & Referral group | Active comparator | Behavioral: Resource & Referral GroupIndividuals randomized to the control group will receive a resource \& Referral service immediately after their baseline research visit. |
| PFR Group | Experimental | Behavioral: PFR GroupIndividuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Primary caregiver for a child aged 10 to 30 months
- Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
- Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
- Caregiver has telephone access
- Caregiver is willing to have researchers come to their house
Key exclusion criteria (4 listed)
- Hospitalized or imprisoned
- Living in a Treatment facility or shelter
- Unable to give consent
- Live in a household that already has a dyad enrolled in the study.
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 |
|---|---|---|
| PFR GroupThe intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session begins with a brief discussion and education on the target topic for that week . Then 20 minutes is spent on video recording a structured interaction between the caregiver and child or viewing the previous session's recording and engaging in reflective discussion about successful caregiving strategies and child's response to caregiver behavior (alternating weeks). Trained PFR specialists who are community members use the 5 "consultation strategies," labeled Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts. | Behavioural | PFR Group |
| Resource & Referral GroupThe Resource \& Referral program consists of 1) an initial needs assessment to determine if the enrolled family has any unmet needs (housing, financial, health, mental health, etc…), 2) a tailored resource and referral packet will be mailed to the participant with the most important referrals marked, 3) a follow-up call will be made two weeks after mailing the packet to verify that the participant has received it, and 4) a second follow-up call will be made three months after the initial session, to assess types of services actually received, barriers to receiving services, and reassessing resources needed and providing additional referrals if needed. | Behavioural | Resource & Referral group |
Primary outcome
Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months
Time frame: Baseline, 3-month and 6-month follow-ups
We are using the Nursing Child Assessment Satellite Training Teaching Scales to assess quality of caregiver-child interactions. Caregivers select an activity that their child cannot perform, such as drawing, and spend up to 5 minutes teaching this activity to the child. The interaction is video-recorded and coded for the caregiver's sensitivity to cues, response to distress, and fostering of social, emotional, and cognitive growth, as well as for the child's clarity of cues and responsiveness to the caregiver.
3 secondary outcomes
Change in Caregiver helplessness from baseline at 3 months and 6 months
Time frame: Baseline, 3-month and 6-month follow-ups
Change in Caregiver stress from baseline at 3 months and 6 months
Time frame: Baseline, 3-month and 6-month follow-ups
Change in Child Social-emotional Competence from baseline at 3 months and 6 months
Time frame: Baseline, 3-month and 6-month follow ups
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 2 Sep 2021.
- Background: PubMed 32216455Oxford M, Booth-LaForce C, Echo-Hawk A, Madesclaire O, Parrish L, Widner M, Petras A, Abrahamson-Richards T, Nelson K, Buchwald D; CATCH Project Team. Promoting First Relationships(R): Implementing a Home Visiting Research Program in Two American Indian Communities. Can J Nurs Res. 2020 Jun;52(2):149-156. doi: 10.1177/0844562120914424. Epub 2020 Mar 26.
- Derived from this study: PubMed 36227860Booth-LaForce C, Oxford ML, O'Leary R, Rees J, Petras A, Buchwald DS. Implementation fidelity of the Promoting First Relationships intervention program in a Native community. Transl Behav Med. 2023 Jan 20;13(1):34-41. doi: 10.1093/tbm/ibac060.
- 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.
Cathryn Booth-LaForce, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFR Group and Resource & Referral Group in people with Parent-child Interaction, run by University of Washington 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 7 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: finished, as of the sponsor's last update on 2 Sep 2021. 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?
Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months (time frame: Baseline, 3-month and 6-month follow-ups). 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 NCT02139332, which also lists 2 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 2 Sep 2021.