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A Primary Prevention Trial to Strengthen Child Attachment in a Native Community (FPT PFR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139332
Recruitment Status : Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Cathryn Booth-LaForce, University of Washington

Brief 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 this community.

Condition or disease Intervention/treatment Phase
Parent-child Interaction Behavioral: PFR Group Behavioral: Resource & Referral Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Primary Prevention Trial to Strengthen Child Attachment in a Native Community
Actual Study Start Date : June 2015
Actual Primary Completion Date : March 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Resource & Referral group
Individuals randomized to the control group will receive a resource & Referral service immediately after their baseline research visit.
Behavioral: Resource & Referral Group
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.

Experimental: PFR Group
Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment.
Behavioral: PFR Group
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Caregiver helplessness from baseline at 3 months and 6 months [ Time Frame: Baseline, 3-month and 6-month follow-ups ]
    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")

  2. Change in Caregiver stress from baseline at 3 months and 6 months [ Time Frame: Baseline, 3-month and 6-month follow-ups ]
    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.

  3. Change in Child Social-emotional Competence from baseline at 3 months and 6 months [ Time Frame: Baseline, 3-month and 6-month follow ups ]
    Children's social-emotional competencies are measured with the Infant-Toddler Social Emotional Assessment, a caregiver-report questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Primary caregiver for a child aged 10 to 30 months
  2. Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
  3. Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
  4. Caregiver has telephone access
  5. Caregiver is willing to have researchers come to their house
  6. Caregiver is English speaking
  7. Caregiver is willing to participate in a home-visiting program which includes video-recorded sessions of caregivers and their children playing

Exclusion Criteria: Caregiver is

  1. Hospitalized or imprisoned
  2. Living in a Treatment facility or shelter
  3. Unable to give consent
  4. Live in a household that already has a dyad enrolled in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139332


Locations
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United States, Montana
Health Promotion Disease Prevention Program
Poplar, Montana, United States, 59255
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Cathryn Booth-LaForce, PhD University of Washington
Publications:
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Responsible Party: Cathryn Booth-LaForce, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT02139332    
Other Study ID Numbers: 45359-G
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cathryn Booth-LaForce, University of Washington:
Attachment theory
Parent- child relationship
Child mental health
Behavioral health