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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new web-based program called the EMPOWER Program, designed to help parents reduce behaviors that might worsen their child's anxiety. The goal is to determine if this quick, self-guided session can lessen parents' involvement in their child's anxiety and, in turn, ease the child's symptoms over time while they wait for traditional therapy. Parents whose children have anxiety or OCD and are stuck on long waitlists for cognitive behavioral therapy (CBT) might find this trial particularly relevant. Participants will either try the EMPOWER Program or remain on the waitlist as usual, helping researchers understand its impact. As an unphased trial, this study offers a unique opportunity for parents to potentially improve their child's well-being while contributing to valuable research.

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 prior data suggests that The EMPOWER Program is safe for parents and children?

Research has shown that The EMPOWER Program is a safe and well-received option for parents. One study involving 301 parents found that the program effectively reduced behaviors that can worsen child anxiety. No major negative effects were reported, indicating that both parents and children found the program safe and helpful.

The EMPOWER Program is an online, self-guided session for parents, teaching skills like building bravery and reducing anxiety in children. This approach offers a promising and safe way to support children with anxiety, especially when traditional therapies are not immediately available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPOWER Program because it offers a fresh, convenient approach to addressing child anxiety. Unlike traditional treatments, which often require multiple therapy sessions over a long period, this program is a single-session intervention that parents can complete online in just 30 minutes. It’s based on cognitive-behavioral therapy (CBT) principles but is self-administered, making it more accessible and less time-consuming for busy families. Plus, the web-based format means it can reach a wider audience, potentially helping more children manage anxiety effectively.

What evidence suggests that The EMPOWER Program might be an effective treatment for child anxiety?

Research has shown that The EMPOWER Program, a self-guided online session, effectively helps parents reduce behaviors that can worsen their child's anxiety. Participants in this trial may receive The EMPOWER Program, which studies have found significantly decreases "parental accommodation," where parents alter their actions to help their anxious child avoid feared situations. Research suggests that programs focusing on parents can be as effective as traditional therapies that focus directly on children. Early findings indicate that The EMPOWER Program might also reduce anxiety symptoms in children, making it a promising option for families awaiting more intensive therapy. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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).

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

Parents will be excluded if:

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8292931/

Empowering Anxious Parents to Manage Child Avoidance ... Project EMPOWER is an acceptable self-guided SSI for parents of children at-risk for anxiety, which yields proximal reductions in clinically relevant targets.

2. osf.io osf.io/preprints/osf/nyb9s

Project EMPOWER: A Randomized Controlled Trial of Web ... This study evaluated the effects of Project EMPOWER, an evidence-based SSI designed to help reduce parental accommodation.

3. withpower.com withpower.com/trial/phase-anxiety-disorders-8-2023-f3649

Single Session Parenting Intervention 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.

4. researchprotocols.org researchprotocols.org/2022/11/e40707/

Effectiveness of a Web-Based Intervention to Prevent ... This study seeks to evaluate the feasibility of delivering this web-based intervention and assess its effectiveness in reducing child anxiety symptoms.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317650/

Effectiveness of a Parent Empowerment Program for ... This study evaluated the effectiveness of a parent empowerment program combining parental training and motivational interviewing to support ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34255718/

Empowering Anxious Parents to Manage Child Avoidance ... Project EMPOWER is an acceptable self-guided SSI for parents of children at-risk for anxiety, which yields proximal reductions in clinically relevant targets.

7. schleiderlab.org schleiderlab.org/empower.html

Project EMPOWER Project EMPOWER is a free, science-backed, 1-session online program for parents, teaching skills to build bravery and reduce anxiety in children and pre-teens.