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Trial record 21 of 2644 for:    ( Map: Idaho, United States )

Beginning Relationships in a Native Community (P20-RP3)

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ClinicalTrials.gov Identifier: NCT02091804
Recruitment Status : Unknown
Verified October 2017 by Cathryn Booth-LaForce, University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Washington State University
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/wait list group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Maternal and Child Health program, and to assess the efficacy of the method in this community.

Condition or disease Intervention/treatment Phase
Parent-child Interaction Behavioral: Immediate Group Behavioral: Wait-List group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Promoting First Relationships: A Strengths-based Primary Prevention Project in a Native Community
Study Start Date : September 2014
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Wait-List group
Individuals randomized to the control group will receive the intervention program immediately after their 3-month research visit.
Behavioral: Wait-List group
The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session lasts approximately 30 minutes, and begins with brief (~10 min) discussions and education on the target topic for that week . The remaining 20 minutes will alternate between 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. 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.

Experimental: Immediate Group
Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment.
Behavioral: Immediate Group
The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session lasts approximately 30 minutes, and begins with brief (~10 min) discussions and education on the target topic for that week . The remaining 20 minutes will alternate between 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. 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



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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): NCT02091804


Locations
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United States, Idaho
Nimiipuu Health Community Clinic
Lapwai, Idaho, United States, 83540
Sponsors and Collaborators
University of Washington
National Institute on Minority Health and Health Disparities (NIMHD)
Washington State University
Investigators
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Principal Investigator: Cathryn Booth-LaForce, PhD University of Washington

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Responsible Party: Cathryn Booth-LaForce, Professor, Dept. of Family and Child Nursing, University of Washington
ClinicalTrials.gov Identifier: NCT02091804     History of Changes
Other Study ID Numbers: 45360
1P20MD006871 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
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