Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)

Despite strong evidence for the efficacy of individual cognitive-behavior therapy (ICBT) for
childhood anxiety disorders, up to 50% of children remain symptomatic after treatment and
many still meet diagnostic criteria. Evidence for parental influences in the etiology and
maintenance of anxiety in children has often led to the reasonable assumption that adding
parent work to ICBT would enhance treatment effects. This idea has now been repeatedly tested
in randomized controlled trials (RCTs) that compared ICBT to ICBT with added parent work. The
specific content of the parent work has varied but has mainly included teaching parents
skills for contingency management, modeling appropriate behavior, and reducing family
conflict. Working with parents in these ways has so far not led to enhanced treatment effects
compared to ICBT alone, as a number of meta-analytic and comprehensive reviews have shown.

One plausible conclusion from these data is that parent work cannot enhance effects beyond
what is achieved through ICBT alone. This study focuses on an alternative plausible
conclusion: That parent interventions need to be informed by theoretical working models of
parent-specific mechanisms of change that are not targeted in ICBT; and that parent
interventions need to be evaluated in explanatory RCTs that ask not only 'does treatment
work?' but also 'how and for whom does treatment work?' Underlying systems that shape how
parents respond to child anxiety or distress can provide clues to parent-specific targets for
intervention and can point to potential moderators of treatment response. Identifying
mechanisms by which parent interventions can enhance child anxiety outcomes, and identifying
markers of parents most in need of such interventions advances the goal of personalized
psychotherapy, and is the overall goal of this study.

Family accommodation (FA) describes parents' attempts to help a child avoid feeling anxious
by participating in symptom-driven behaviors and modifying family routines. FA is highly
prevalent among parents of anxious children and has been linked to greater symptom severity
in the child and to poorer response to ICBT. Research has linked a number of biological and
behavioral parent markers to protective parental behavior and to child anxiety. The
nonapeptide oxytocin (OT) is implicated in parental attachment and protective behavior in
humans and animals. Coded behavioral observations link aspects of parental behavior (i.e.,
autonomy granting, over involvement, and sensitivity) to child anxiety. A number of studies
also have shown that these biological and behavioral markers interact to predict anxiety
outcomes in at-risk children. Yet so far this research has been siloed from intervention
research and has not informed parent-based treatments, highlighting the need for clinical
investigators equipped with the necessary skills to integrate multiple units of analysis into
explanatory RCTs of novel interventions.

This study represents a fusion of clinical, biological and behavioral research through an
explanatory RCT of a parent-based treatment focused on modifying parental responses to child
anxiety and distress as a mediator of treatment outcome, and on biological and behavioral
markers as possible moderators of treatment outcome. The intervention evaluated in this study
(Supportive Parenting for Anxious Childhood Emotions; SPACE) aims to systematically reduce FA
through a series of concrete manualized steps. This study is an integrated explanatory RCT of
SPACE with the following 3 specific aims:

Aim 1 - Specificity: Does SPACE lead to significantly lower levels of FA compared to ICBT?
Hypothesis: Levels of FA for parents in SPACE will be significantly lower after treatment
than before treatment, as compared to parents of children in ICBT.

Aim 2 - Mediation: Does reducing FA lead to positive child outcomes? Hypothesis: Parents'
reduced FA will be a significant mediator of positive child outcomes (i.e., reduced child
anxiety).

Aim 3 - Moderation: Do key biological and behavioral markers (i.e., parental OT, autonomy
granting, over involvement, sensitivity) moderate child outcomes? Hypothesis: Baseline levels
of maternal OT, autonomy granting, over involvement, and sensitivity will be significant
moderators of child outcomes (i.e., reducing child anxiety).

Inclusion Criteria:

Children:

- meet criteria for a primary DSM5 anxiety disorder of generalized anxiety disorder
(GAD), social phobia (SOP), and separation anxiety disorder (SAD) using the DSM-5
version of the Anxiety Disorders Interview Schedule -Child and Parent Versions
(ADIS-C/P)

- mean score of 4 or greater on the ADIS-C/P Clinician Rating Scale of Severity (CSR)

- ceasing all other psychosocial treatment upon consultation with the clinic staff and
the service provider

- not using any psychotropic medication other than a stable dose of stimulant medication
treatment for comorbid ADHD or a stable dose of Selective Serotonin Reuptake Inhibitor
(SSRI)

- children who are on a stable dose of stimulant medication or SSRI (i.e., a minimum of
six weeks at the same dose) will be included so as not to limit generalizability.

Exclusion Criteria:

Children:

- primary diagnosis of any Axis I DSM-IV disorder other than GAD, SOP, Phobias and SAD

- any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive
Developmental Disorders, Mental Retardation, Organic Mental Disorders, Bipolar
Disorder, Schizophrenia and Other Psychotic Disorders

- drug or alcohol abuse/dependence will also be exclusionary

- tic disorders will not be exclusionary unless they require psychotropic medication to
stabilize

- Significant active suicidal ideation or a past suicide attempt in the last 6 months.
Adolescents with a history of non-lethal self-harm behaviors (e.g., cutting) will be
allowed to enroll if they meet other criteria

- have an intellectual disability as reported by guardian

- be a victim of past or present undisclosed abuse requiring investigation or ongoing
supervision by the Department of Social Services

- not have been cohabiting with mother for at least one year prior to admittance.
Parent:

- any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive
Developmental Disorders, Mental Retardation, Selective Mutism, Organic Mental
Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders. Drug or
alcohol abuse/dependence will also be exclusionary

- not have been cohabiting with child for at least one year prior to admittance

- report the presence of any active suicidal ideation or a past suicide attempt in the
last 6 months.