Single Session Parenting Intervention for Child Anxiety

Overseen By Madelaine R Abel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Suicidal ideation, Psychosis, Severe mood, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

54 Participants Needed

Trial Summary

What is the purpose of this trial?

Cognitive Behavioral Therapy (CBT) is the treatment of choice for youth anxiety. However, up to 80% of youth with anxiety disorders do not access the services they need. Child CBT clinics nationwide have extremely long waits, on the order of 10-12 months. This leads to a vicious cycle, as children waiting for care experience worsening symptoms and decreased motivation, so that by the time they access care, their needs are more intensive and the treatment lasts longer and it takes longer for new children to be able to be assigned. Recently, single-session interventions (SSIs) have been developed that enable children to access CBT skills. The proposed randomized trial will evaluate the effects of a brief, web-based, self-guided SSI designed to reduce parent accommodation of children's anxiety, a parenting behavior that has been shown to maintain and worsen child anxiety. The main aim of the study is to examine whether the SSI reduces parent accommodation. As a secondary aim, the investigators will explore whether the SSI reduces children's anxiety symptoms over the first 6 months of CBT. The investigators will recruit parents of children who are on the waitlist to receive outpatient CBT. Results may suggest a promising approach to intervene with parents and children waiting to receive therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a parenting intervention for child anxiety, so it's best to consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment The EMPOWER Program for child anxiety?

Research shows that parent-based treatments, like The EMPOWER Program, can be as effective as traditional child-focused therapies for reducing child anxiety. Studies indicate that involving parents in therapy helps manage anxiety by reducing behaviors that accommodate or reinforce the child's anxiety. ^{1 2 3 4 5}

How does the Single Session Parenting Intervention for Child Anxiety differ from other treatments for this condition?

This treatment is unique because it focuses on a single session parent-based intervention, which aims to reduce parental accommodation of child anxiety, unlike traditional child-focused therapies like cognitive-behavioral therapy (CBT). It empowers parents to manage their child's anxiety more effectively, potentially offering a more accessible and less time-consuming alternative to multi-session therapies. ^{2 3 4 6 7}

Eligibility Criteria

This trial is for parents over 18 whose children, aged 5-12, have anxiety or OCD but aren't currently receiving CBT. Parents must speak English and their child shouldn't have severe mood disorders, psychosis, or suicidal thoughts.

Inclusion Criteria

My parents are adults.

My child is between 5 and 12 years old.

Parents will be eligible to participate if:

Exclusion Criteria

Their child is already receiving CBT (i.e., transfer cases from other CBT providers in the community).

Parents will be excluded if:

My child has severe mood or behavior issues, not just anxiety.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Session Intervention

Parents participate in the EMPOWER Program, a 30-minute web-based, self-guided SSI targeting parent accommodation of children's anxiety

30 minutes

1 visit (virtual)

Follow-up

Participants are monitored for changes in parental accommodation and child anxiety symptoms

2 weeks

1 visit (virtual)

Extended Follow-up

Monitoring of children's anxiety symptoms over the first 6 months of CBT

6 months

3 visits (virtual)

Treatment Details

Interventions

• The EMPOWER Program

Trial Overview The EMPOWER Program's single-session intervention (SSI) is being tested to see if it can reduce how much parents change their behavior to accommodate their child's anxiety while waiting for outpatient therapy.

Participant Groups

Group I: The EMPOWER Program Experimental Treatment 1 Intervention

The EMPOWER Program (Sung et al., 2021) is a web-based, self-administered SSI for parents that takes about 30 minutes to complete. The SSI includes 5 elements based on the components of CBT.

Group II: Waitlist as Usual Active Control 1 Intervention

Participants in the control group will have their children remain on the waitlist until they are assigned to a therapist in the clinic.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

AIM Youth Mental Health

Collaborator

Trials

2

Recruited

70+

American Psychological Foundation

Collaborator

Trials

20

Recruited

2,200+

Findings from Research

In a study involving 12 children with anxiety disorders in Japan, guided parent-delivered cognitive behavioural therapy (GPD-CBT) showed promising results, with 40% of participants free from their primary diagnoses immediately after treatment and 70% at a one-month follow-up.

The effectiveness of GPD-CBT in reducing anxiety symptoms in Japanese children aligns with findings from Western studies, suggesting it could be a valuable low-intensity treatment option to improve access to psychological therapies in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided parent-delivered cognitive behavioural therapy for Japanese children and parents: a single-arm uncontrolled study. Okawa, S., Arai, H., Nakamura, H., et al.[2023]

A brief online cognitive behavioral intervention for parents of anxious children (ages 4-10) showed high acceptability and retention rates (68.4%), indicating that parents found the program useful and engaging.

The intervention resulted in moderate to large effect sizes for parent-rated outcomes, suggesting positive changes in parental confidence and efficacy, while also benefiting children, although child self-reported anxiety showed smaller changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Cognitive Behavioural Intervention for Parents of Anxious Children: Feasibility and Acceptability Study. Jewell, C., Wittkowski, A., Collinge, S., et al.[2023]

In a study involving 211 children with anxiety disorders and their mothers, adding treatments for maternal anxiety or focusing on mother-child interactions did not significantly improve child anxiety outcomes compared to standard cognitive-behavioral therapy (CBT) alone.

However, the intervention targeting mother-child interactions showed some benefits in reducing maternal overinvolvement and was found to be a cost-effective approach, with a 75% probability of being cost-effective compared to standard CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of childhood anxiety disorder in the context of maternal anxiety disorder: a randomised controlled trial and economic analysis. Creswell, C., Cruddace, S., Gerry, S., et al.[2022]

The study involved 124 children aged 7-14 with primary anxiety disorders, comparing the efficacy of the parent-based treatment SPACE to traditional cognitive-behavioral therapy (CBT).

SPACE was found to be noninferior to CBT in reducing anxiety symptoms and was particularly effective in decreasing family accommodation, making it a viable alternative treatment for childhood anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. Lebowitz, ER., Marin, C., Martino, A., et al.[2021]

A parent-directed group cognitive behavioral therapy (CBT) intervention for 42 children aged 6-12 with anxiety disorders led to significant improvements in parents' depressive symptoms and family functioning, as well as reductions in children's emotional symptoms.

Clinician assessments indicated that children's functioning improved significantly after the CBT intervention, suggesting that involving parents in treatment can effectively manage childhood anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-only Group Cognitive Behavioral Intervention for Children with Anxiety Disorders: A Control Group Study. Salari, E., Shahrivar, Z., Mahmoudi-Gharaei, J., et al.[2022]

The study involved 25 parents and demonstrated that the group implementation of SPACE (Supportive Parenting for Anxious Childhood Emotions) significantly reduced parental accommodation of children's anxiety symptoms, as well as family power struggles and parental feelings of helplessness.

Following the SPACE treatment, there was also a notable reduction in the severity of anxiety and OCD symptoms in children, highlighting the potential effectiveness of parent training as an alternative to direct child therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of a Parent Group Treatment for Youth with Anxiety Disorders and Obsessive Compulsive Disorder. Dekel, I., Dorman-Ilan, S., Lang, C., et al.[2021]

Parents of kindergarten-aged children with anxiety reported that their children's anxiety significantly impacts the entire family, highlighting the need for supportive interventions.

The study revealed that while parents often reacted to their child's anxiety without a consistent strategy, they possess strengths that can be harnessed to help mitigate their child's anxiety, suggesting a focus on empowering parents in intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening to parents: the challenges of parenting kindergarten-aged children who are anxious. Hiebert-Murphy, D., Williams, EA., Mills, RS., et al.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Guided parent-delivered cognitive behavioural therapy for Japanese children and parents: a single-arm uncontrolled study. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A Brief Cognitive Behavioural Intervention for Parents of Anxious Children: Feasibility and Acceptability Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of childhood anxiety disorder in the context of maternal anxiety disorder: a randomised controlled trial and economic analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Parent-only Group Cognitive Behavioral Intervention for Children with Anxiety Disorders: A Control Group Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Feasibility of a Parent Group Treatment for Youth with Anxiety Disorders and Obsessive Compulsive Disorder. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Listening to parents: the challenges of parenting kindergarten-aged children who are anxious. [2012]