Intervening to enhance cortisol regulation among children at risk for neglect: Results of a randomized clinical trial

May combine two claims.

Child age was negatively correlated with log-transformed bedtime cortisol on day 1 and day 2, and with log-transformed wake-up cortisol on day 3.

“Child age was negatively correlated with log-transformed bedtime cortisol levels on day 1 (r = -.36, p = .001) and day 2 (r = -.24, p < .05), and with log-transformed wake-up cortisol levels on day 3 (r = -.38, p < .05).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Families in the study varied in their histories of neglect.

“However, families in the current study varied with regard to histories of neglect.”

May combine two claims.

Intervention group significantly predicted the change in cortisol across the day, with ABC children showing a steeper wake-up-to-bedtime decline than DEF children.

“There was a significant effect of intervention group on the change in cortisol across the day, with children in the ABC group showing a steeper wake-up to bedtime pattern (i.e., more negative slope) than children in the DEF intervention group (β11 = -0.15, p = 0.051).”

• AssumptionRests on an assumption: The control (DEF) intervention does not itself affect children's diurnal cortisol regulation.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Sample collection time was unrelated to cortisol at all time points but was included as a covariate based on prior studies.

“Although time of sample collection was not associated with cortisol values at any of the time points (p values > .05), it was included as a covariate in primary analyses based on previous”

Probably not a substantial claim: may not pass S3 (load-bearing).

All intervention sessions were videotaped, allowing supervision and fidelity monitoring.

“All sessions were videotaped, which allowed supervision and fidelity monitoring.”

May combine two claims.

Preschoolers assigned to Multidimensional Treatment Foster Care showed steeper morning-to-evening cortisol slopes than those in regular foster care, while control children continued to show blunted reactivity.

“Fisher et al. (2007) found that preschoolers (the majority with prior experiences of neglect) assigned to an experimental condition (Multidimensional Treatment Foster Care) showed steeper slopes from morning to evening than those receiving regular foster care. Those assigned to the control intervention continued to show a persisting pattern of blunted cortisol reactivity typical of neglected”

• cites Fisher et al., 2007Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

ABC has been shown to improve attachment security.

“Bernard et al. (2012) have previously shown that the ABC intervention was effective in enhancing attachment security.”

• cites Bernard et al., 2012 sourceNot checked yet

  Not checked in the free run.

May combine two claims.

Whether a given cortisol sample was missing was not related to cortisol levels from the other available samples, as all tests were non-significant.

“All of these were non-significant (ps > .05), indicating that there was no association between whether a particular cortisol sample was missing and cortisol level based on available observed measurements.”

May combine two claims.

Neglected children show a flatter diurnal cortisol slope and lower wake-up values than non-neglected children.

“In particular, neglected children have shown a flatter slope with lower wake-up values relative to non-neglected children.”

• cites Bernard et al., 2010; Kroupina et al., 2012Not checked yet

  Not checked in the free run.

• AssumptionRests on an assumption: Cortisol follows a diurnal pattern with high wake-up and low bedtime values.

Probably not a substantial claim: may not pass S3 (load-bearing).

Post-intervention retention was 183 children, or 86% of the 212 enrolled.

“As can be seen from Figure 1, 183 participants were retained during the post-intervention phase of the study (representing 86% of the 212 children enrolled in the intervention).”

May combine two claims.

Foster infants whose caregivers completed ABC showed more normative cortisol production than foster infants in a control condition, with levels comparable to a low-risk comparison group.

“Dozier, Peloso, et al. (2006) found that foster infants whose caregivers completed the ABC intervention showed a more normative pattern of cortisol production following the intervention than did foster infants in a control intervention condition. More specifically, foster infants who received the ABC intervention showed lower levels of cortisol that were comparable to a low-risk comparison group,”

• cites Dozier, Peloso, et al., 2006Not checked yet

  Not checked in the free run.

Classified as probably not a substantial claim. May combine two claims.

Both groups received identical assessments, and the interventions matched in length and session frequency.

“All pre- and post-intervention assessments were the same for the two groups, and the two interventions were of the same duration (i.e., ten 1-hour sessions) and frequency (i.e., weekly).”

May combine two claims.

Flatter, lower daily cortisol profiles predict greater risk of mood disorders, aggression, and conduct problems.

“there is evidence that low, flat diurnal cortisol patterns are associated with increased risk for mood disorders (Gunnar & Vazquez, 2001), aggression (McBurnett, Lahey, Rathouz, & Loeber, 2000), and conduct problems (Pajer, Gardner, Rubin, Perel, & Neal, 2001).”

• cites Gunnar & Vazquez, 2001; McBurnett et al., 2000; Pajer et al., 2001Not checked yet

  Not checked in the free run.

May combine two claims.

Before intervention, ABC and DEF groups did not differ in wake-up cortisol, bedtime cortisol, or wake-up-to-bedtime cortisol slope.

“At pre-intervention, children randomly assigned to receive the ABC intervention or control (DEF) intervention did not differ with regard to wake-up cortisol levels (β01 = 0.14, p > .05), bedtime cortisol levels (β01 = -.01, p > .05), or wake-up to bedtime slope in cortisol production (β11 = -0.15, p > .05).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Cortisol values above 2.0 were treated as biologically implausible and deleted, and values more than 3 SD above the mean were excluded as outliers.

“biologically implausible cortisol values (i.e., defined as values greater than 2.0) were deleted. Additionally, cortisol values greater than 3 SDs above the mean were considered outliers and excluded from analyses.”

May combine two claims.

Human infants with organized attachments do not show a cortisol increase to the Strange Situation, whereas infants with disorganized attachments do.

“human infants with organized attachments do not show an increase in cortisol to the Strange Situation, a procedure involving maternal separations, whereas infants with disorganized attachments do show a cortisol response (Bernard & Dozier, 2010; Gunnar, Broderson, Nachmias, Buss, & Rigatuso, 1996).”

• cites Bernard & Dozier, 2010; Gunnar, Broderson, Nachmias, Buss, & Rigatuso, 1996Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Cortisol was measured with a high-sensitivity salivary enzyme immunoassay; intra- and inter-assay variation stayed under 3.7% and 6.4%.

“Samples were assayed using a high-sensitivity salivary cortisol enzyme immunoassay kit (Salimetrics, LLC, State College, Pennsylvania). All samples from a child were assayed in duplicate on the same plate to minimize variability. The intra-assay and interassay coefficients of variation fell below 3.7% and 6.4%, respectively.”

May combine two claims.

Maltreated infants receiving care as usual showed progressively lower morning cortisol across two years, whereas those receiving parenting interventions remained similar to a nonmaltreated comparison group.

“Whereas maltreated infants receiving care as usual showed progressively lower levels of morning cortisol across the 2-year period, cortisol levels of maltreated infants who received either of the early parenting interventions remained similar to children in a nonmaltreated comparison group.”

• cites Cicchetti et al., 2011Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

The interval from the final session to saliva sampling did not differ between intervention groups.

“There were no intervention group differences in the time between the last session and the time of saliva sample data collection.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Adding flavored crystals has little effect on cortisol measured by radioimmunoassay.

“Controlled studies have reported that flavored crystals only minimally affect cortisol levels when radioimmunoassay is used (Gordon, Peloso, Auker, & Dozier, 2005; Talge, Donzella, Kryzer, Gierens, & Gunnar, 2005).”

• cites Gordon, Peloso, Auker, & Dozier, 2005; Talge, Donzella, Kryzer, Gierens, & Gunnar, 2005Not checked yet

  Not checked in the free run.

May combine two claims.

Missingness was unrelated to child demographic variables or intervention group.

“Missingness was not associated with child demographic variables or intervention group (ps > .05).”

Classified as probably not a substantial claim.

The final sample for the present study was 101 children after excluding unusable cortisol samples.

“resulting in a sample size for the present study of 101 children.”

May combine two claims.

Before intervention, ABC and DEF groups did not differ in child age, caregiver age, or minority status.

“There were no pre-intervention differences between the ABC and DEF groups in child or caregiver age and percentage of minority versus non-minority participants (p values > .05).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Actual time of waking was not consistently available across participants.

“Although it is important to also consider the actual time of waking with respect to the sample collection time, this information was not consistently available across participants.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In rodents and humans, the stress hypo-responsive period depends on having a sensitive mother.

“Among rodents and humans, the availability of a sensitive mother is necessary to maintain this stress hypo-responsive period (Levine, 2001).”

• cites Levine, 2001Not checked yet

  Not checked in the free run.

May combine two claims.

Early adversity is associated with a blunted diurnal cortisol pattern, with high-risk children showing blunted production across the day.

“Early adversity has been associated with a blunting of this diurnal pattern, with children living under high-risk conditions showing a blunted pattern of cortisol production across the day (Bernard et al., 2010; Kroupina et al., 2012).”

• cites Bernard et al., 2010; Kroupina et al., 2012Not checked yet

  Not checked in the free run.

• AssumptionRests on an assumption: Cortisol follows a diurnal pattern with high wake-up and low bedtime values.

Classified as probably not a substantial claim.

Child age was included as a covariate in primary analyses because of its associations with cortisol and prior findings.

“Given these associations and findings from previous studies (e.g., Larson et al., 1998; Watamura, Donzella, Kertes, & Gunnar, 2004), child age was included as a covariate in primary analyses.”

• cites Larson et al., 1998Not checked yet

  Not checked in the free run.

• cites Watamura, Donzella, Kertes, & Gunnar, 2004Not checked yet

  Not checked in the free run.

Classified as probably not a substantial claim.

Parents were randomly assigned to receive either ABC or DEF immediately after providing consent.

“After consenting, parents were randomly assigned to receive either the Attachment and Biobehavioral Catch-up (ABC; experimental) intervention or the Developmental Education for Families (DEF; control) intervention. Randomization occurred immediately after a parent provided consent.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Of 488 possible cortisol samples, 406 were analyzed; 3.7% were removed as outliers and 13.1% were missing because of insufficient saliva or no collection.

“Of 488 possible samples, 406 were included in analyses, with 3.7% removed as outliers and 13.1% missing due to an inadequate volume of saliva or because no sample was collected.”

May combine two claims.

Cicchetti et al. intervened with a similar population of infants living with maltreating parents but used a laboratory cortisol assessment rather than diurnal pattern.

“Cicchetti et al. (2011) intervened with a similar population of infants that were living with their maltreating parents, but examined a laboratory assessment of cortisol, rather than the diurnal pattern.”

• cites Cicchetti et al. (2011)Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

High cortisol has also been observed in other maltreated subgroups, including foster children with severe emotional maltreatment and post-institutionalized children with growth delays.

“high levels of cortisol have also been observed among other subsets of maltreated children, including foster children that experience severe emotional maltreatment (Bruce et al., 2009), as well as in post-institutionalized children with significant growth delays (Kertes et al., 2008).”

• cites Bruce et al., 2009Not checked yet

  Not checked in the free run.

• cites Kertes et al., 2008Not checked yet

  Not checked in the free run.

May combine two claims.

The ABC intervention's effectiveness has been demonstrated for behavioral outcomes such as attachment organization and cognitive flexibility, and for biological outcomes.

“Given that the effectiveness of the ABC intervention has now been demonstrated on both behavioral outcomes (i.e., attachment organization, Bernard et al., 2012; cognitive flexibility, Lewis-Morrarty, Dozier, Bernard, Terracciano, & Moore, 2012) and biological outcomes”

• cites Bernard et al., 2012 sourceNot checked yet

  Not checked in the free run.

• cites Lewis-Morrarty, Dozier, Bernard, Terracciano, & Moore, 2012Not checked yet

  Not checked in the free run.

May combine two claims.

Although pre-intervention cortisol comparability was established for a subset, the study lacked a low-risk comparison group.

“Further, although we established between-group comparability in cortisol profiles for a subset of children at pre-intervention, we did not have cortisol data from a low-risk comparison group.”

May combine two claims.

A steeper slope and higher wake-up cortisol may reflect a more normative diurnal pattern for young children living with high-risk birth parents.

“we suggest here that a steeper slope and higher wake-up cortisol values may reflect a more normative diurnal pattern among young children living with their high-risk birth parents.”

• AssumptionRests on an assumption: The control (DEF) intervention does not itself affect children's diurnal cortisol regulation.

Classified as probably not a substantial claim. May combine two claims.

It is unclear whether cortisol patterns became more typical over time in ABC, more atypical in DEF, or both.

“Thus, it is unclear whether cortisol patterns became more typical over time for children in the ABC group, or whether cortisol patterns became more atypical (i.e., blunted) over time for children in the DEF group, or both.”

May combine two claims.

Excluding four DEF non-completers, the intervention effect remained for wake-up cortisol and diurnal slope.

“When these 4 non-completers were excluded from analyses, findings held for the effect of the ABC intervention on wake-up cortisol (β01 = 0.19, p < .05), and the diurnal slope (β11 = -0.16, p < 0.05).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Meta-analyses show that maternal sensitivity often predicts child attachment less well than attachment theory would expect.

“Meta-analyses indicate that maternal sensitivity often underperforms in predicting child attachment, relative to its expected role based on attachment theory (De Wolff & van IJzendoorn, 1997; van IJzendoorn, 1995).”

• cites De Wolff & van IJzendoorn, 1997Not checked yet

  Not checked in the free run.

• cites van IJzendoorn, 1995Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

The ABC intervention resembles other short-term interventions that emphasize synchrony and nurturance for at-risk parent-infant populations.

“The ABC intervention is similar to other short-term interventions that emphasize the importance of synchrony and nurturance for at-risk parent-infant populations in general (Bakermans-Kranenburg, van IJzendoorn, & Juffer, 2003; Hoffman, Marvin, Cooper, & Powell, 2006; Lieberman & van Horn, 2009; van den Boom, 1994).”

• cites Bakermans-Kranenburg, van IJzendoorn, & Juffer, 2003Not checked yet

  Not checked in the free run.

• cites Hoffman, Marvin, Cooper, & Powell, 2006Not checked yet

  Not checked in the free run.

• cites Lieberman & van Horn, 2009Not checked yet

  Not checked in the free run.

May combine two claims.

Excluding one sibling from each sibling pair, the intervention effect remained for wake-up cortisol and was marginal for diurnal slope.

“When one sibling from each pair was excluded from analyses, the intervention effect held for wake-up cortisol (β01 = 0.20, p < .05), and was marginally significant for the diurnal slope (β11 = -0.14, p = 0.07).”

May combine two claims.

Children with the DRD4 7-repeat allele responded to the intervention, while those without it did not.

“More specifically, children with the DRD4 7-repeat allele, which has been associated with increased externalizing problems, were responsive to the intervention, whereas children without the DRD4 7-repeat allele were not.”

• cites Bakermans-Kranenburg, van IJzendoorn, Mesman, Alink, & Juffer (2008)Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

HLM permits participants with missing data because it allows variation in the timing and number of repeated measurements.

“Given that HLM allows for variability in the timing and number of repeated data points, participants can be included even if they are missing 1 or more points of data.”

May combine two claims.

The observed cortisol pattern is an important indicator of intervention effectiveness and suggests that the intervention supports children's cortisol regulation.

“This pattern is an important index of the intervention’s effectiveness, as it suggests that the intervention serves to support children’s cortisol regulation.”

• AssumptionRests on an assumption: The control (DEF) intervention does not itself affect children's diurnal cortisol regulation.

Classified as probably not a substantial claim. May combine two claims.

HLM handles repeated measures by nesting data points within individuals, yielding separate within-person and between-person variance estimates.

“HLM accounts for the non-independence of repeated measures by modeling multiple data points as nested within individuals. This approach allows for separate estimates of within-subject and between-subject variation.”

• cites Raudenbush & Bryk, 2002Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

The neglect experiences in this sample were likely less severe than those that would lead to removal from parental care.

“In general, the experiences of neglect were likely not as severe as those that warrant removal of a child from a parent’s care.”