A Primary Prevention Trial to Strengthen Child Attachment in a Native Community (FPT PFR)
|ClinicalTrials.gov Identifier: NCT02139332|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : November 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parent-child Interaction||Behavioral: PFR Group Behavioral: Resource & Referral Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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")
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139332
|United States, Montana|
|Health Promotion Disease Prevention Program|
|Poplar, Montana, United States, 59255|
|Principal Investigator:||Cathryn Booth-LaForce, PhD||University of Washington|