Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)
Condition: Anxiety Disorders; Anxiety, Separation; Phobic Disorders
MeSH terms: Anxiety Disorders; Phobic Disorders; Anxiety, Separation
Study type: Interventional

Summary: 
      Childhood anxiety disorders are very common, carry tremendous personal and societal costs,
      frequently do not respond adequately to treatment, and involving parents in treatment has so
      far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific
      mechanisms of change that are not targeted in direct child treatment, and to identify markers
      of who is most likely to benefit from parent intervention. This study is an explanatory
      clinical trial of a parent based intervention and of cognitive behavioral therapy, and an
      investigation of biological and behavioral moderators of treatment response.
    

Detailed description: 
      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).
    

Intervention name(s): Parent-Based Treatment of Child and Adolescent Anxiety Disorders; CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supportive Parenting for Anxious Childhood Emotions; Cognitive Behavioral Therapy
Other intervention name(s): SPACE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child; Adolescent; Parents; Cognitive Therapy; Cognitive Behavior Therapy; Anxiety