| Study characteristics |
| Methods |
Study design: individual RCT (parallel groups) Study aim/hypothesis: to contribute new understanding into how parenting intervention outcomes in early childhood may vary between vulnerable families of parents with versus without a history of significant abuse. It was hypothesised that "the impact of Promoting First Relationships (PFR) on enhanced parental sensitivity, and, in turn, increases in secure base behavior, would be evident or more pronounced in the families of parents with versus without an abuse history." (Pasalich 2019, page 58) Study setting: Snohomish, southern Skagit, or northern King County in Washington State, USA. Data collection between 2011 and 2014 Trial registration number: NCT01332851 |
| Participants |
Inclusion criteria: conversant in English; have housing and live in Snohomish, Southern Skagit, or Northern King County in Washington State; have a toddler aged between 10 and 24 months and an open case with an allegation of any type of maltreatment recorded in the database of one of the 6 collaborating child protective services offices at least 2 weeks prior to initial recruitment contact Exclusion criteria: not reported -
N referred and randomised: 384 referred, 247 randomised
N lost to follow‐up (post‐intervention): 19 (7.7%) -
N analysed
Childhood maltreatment and/or complex trauma status: childhood maltreatment Childhood maltreatment and/or trauma assessment: The Childhood Trauma Questionnaire‐Short Form. "Dichotomous cutoff scores were used to measure significant (i.e. 'moderate to severe') levels of physical, sexual, and emotional abuse" Pasalich 2019, page 59). Subsample consisted of mothers with a history of moderate‐severe levels of childhood maltreatment Parenting stage: > 7 weeks postpartum (up to 5 years) Recruitment setting: Washington State Department of Social and Health Services (DSHS) database -
Baseline characteristics
Progress+ coding: low SES |
| Interventions |
Intervention ‐ Promoting First Relationships (PFR)
Category: parenting, parent‐child or relationship focused interventions (parent‐child interventions) Description: a relationship‐ and strengths‐based home visiting service that aims to help families facing adversity Mode of delivery: face‐to‐face, individually Dose: more than 10 hours Length: other ‐ completed over 14 weeks Frequency: weekly Protocol: yes Provider: single practitioner (Master's degrees in social work or counselling) Training: specifics not reported, but the providers completed PFR training over a 5‐month period to become certified. The PFR training model also included weekly reflective practice group sessions, facilitated by a PFR consultant, to support providers in their work with vulnerable families Implementation fidelity: the providers submitted videotapes of themselves working with the families (one videotaped session for each family on their caseload), which the master trainer used to rate the quality of delivery on a 1‐ to 5‐point scale. If a provider did not maintain fidelity (i.e. received a rating < 4 for a videotaped session), they received additional one‐on‐one mentoring until the fidelity to PFR was re‐established. The training model also included weekly reflective practice group sessions. Treatment adherence: 97% of the programme elements were completed, with 86% of families receiving all 10 sessions. Of those who started the PFR intervention, 7% missed between 1 and 9 sessions
Comparator ‐ three‐call resource and referral (R&R)
Category: inactive comparator (attention control) Description: R&R was delivered over the phone in 3 sessions, which consisted of a 30‐minute needs assessment, a mailed packet of personalised information (e.g. local services), and followed up with 2 x 10‐minute check‐in calls Mode of delivery: telephone Dose: less than an hour Length: other ‐ the 3 contacts were spaced across approximately 14 weeks to mirror the average length of the PFR intervention Frequency: not reported Protocol: not reported Provider: single practitioner (social service provider) Training: not reported Implementation fidelity: not reported Uptake of standard care: 89% received all 3 telephone sessions
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| Outcomes |
Assessment time point(s)
Baseline (child, on average, 16 months old) Post‐intervention (< 3 months post‐intervention) 3‐month follow‐up (3 to 12 months post‐intervention) 6‐month follow‐up (3 to 12 months post‐intervention)
Note: secure base behaviour only assessed at baseline and 6‐month follow‐up
Primary outcome(s)
Parent‐child relationship
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Parent sensitivity
Domain: parenting capacity Measure: Nursing Child Assessment Teaching Scale Score range: 0 to 45 Direction of effect: higher scores = better/less harm
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Secure base behaviour
Domain: parenting capacity Measure: Toddler Attachment Sort‐45 Score range: not reported Direction of effect: higher scores = better/less harm
Secondary outcome(s):
Parent engagement
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Dropout
Domain: parental intervention acceptability Measure: dropout for any reason between randomisation and post‐intervention Score range: not applicable Direction of effect: higher events = more dropout
Adverse outcome(s): none specified |
| Notes |
Comment(s)
Authors provided unpublished data for the subgroup (81 participants) of mothers with moderate‐severe levels of maltreatment as assessed on the Childhood Trauma Questionnaire (for any of the 5 maltreatment types) Baseline characteristics, Progress+ coding, enrolment/dropout details includes all participants in the study, unless otherwise specified
Funding source: Eunice Kennedy Shriver National Institute of Child Health and Human Development; Australian Research Council Discovery Early Career Researcher Award
Conflicts of interest: the authors declared that there were no conflicts of interest |
