Parent-Mediated Intervention for Autism

Overseen By Katherine Paszek

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Anxiety medication

Disqualifiers: Hearing impairment, School refusal, others

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

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a parent-led program to assist children with autism who have a strong need for routine and sameness. The study aims to determine if parents can effectively use this program online and if it helps reduce these behaviors in children. The treatment, called Supportive Parenting for Anxious Childhood Emotions (SPACE), is a 16-week program designed to teach parents how to support their children in managing these behaviors. Children aged 6 to 10 years who have autism, a need for sameness, and can participate with an English-speaking parent are well-suited for this trial. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance support for children with autism.

Will I have to stop taking my current medications?

The trial requires that any behavioral and medication treatments for anxiety or insistence on sameness be stable for at least two months before starting the study, and no changes should be made during the trial.

What prior data suggests that this intervention is safe for children with autism?

Research has shown that the SPACE program, which stands for Supportive Parenting for Anxious Childhood Emotions, is generally well-received by parents. In past studies, parents found the program both acceptable and satisfactory. SPACE aims to teach parents how to support their child's emotional needs without yielding to anxiety-driven requests.

No major safety concerns have emerged in the studies. SPACE helps parents learn to reduce behaviors that accommodate anxiety, meaning they don't always give in to a child's anxious demands. This approach has improved anxiety symptoms in children with autism.

While one study found that another program was more effective at reducing anxiety, this does not imply any safety issues with SPACE. Overall, SPACE appears to be a safe and effective way for parents to help their children manage anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for autism, which often focus directly on the child, the Parent-Mediated Intervention for Autism emphasizes empowering parents through a unique approach called Supportive Parenting for Anxious Childhood Emotions (SPACE). This method is exciting because it targets the child's symptoms by enhancing parental skills to manage anxiety and insistence on sameness in their children. Researchers are hopeful that by involving parents directly, this intervention could lead to more sustainable and impactful improvements in children's behavior, potentially offering a new avenue for support beyond traditional therapies.

What evidence suggests that this intervention is effective for autism?

Research has shown that the Supportive Parenting for Anxious Childhood Emotions (SPACE) program, which participants in this trial will receive, can help reduce anxiety in children with autism. A small initial study found that SPACE was practical and well-received by families, indicating it can help manage anxiety symptoms. However, another study found that a different program, FTTT, was more effective than SPACE in reducing anxiety and the extent to which families adjust their routines. Despite this, SPACE has shown promise in lessening parental stress in other situations. While direct evidence about its effect on repetitive behaviors in autism is limited, SPACE's success in addressing anxiety suggests it could be beneficial. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer Phillips, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English-speaking children aged 6 to almost 11 with Autism Spectrum Disorder (ASD) who have an IQ of 75 or higher. They must show behaviors of insistence on sameness, and their parents should be able to participate in virtual sessions. Children cannot join if they don't meet these specific criteria.

Inclusion Criteria

I am between 6 and 10 years old.

IQ > or = 75 (based on history, review of available medical records)

Report three or more family accommodations for insistence on sameness based on screening measures

Exclusion Criteria

I am receiving help for anxiety or need for routine.

Caregivers who have participated in formal SPACE training

My child has a history of avoiding school, self-harm, or thinking about suicide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 16-week parent-mediated intervention for insistence on sameness behaviors via telehealth

16 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Supportive Parenting for Anxious Childhood Emotions (SPACE)

Trial Overview The study tests a virtual program called Supportive Parenting for Anxious Childhood Emotions (SPACE), adapted for 'insistence on sameness' behaviors in autistic children. It aims to see if caregivers can effectively use the method through telehealth and if it improves the children's behavior.

How Is the Trial Designed?

Group I: Active treatment Experimental Treatment 1 Intervention

Eligible participants that enroll will received 16 week parent based intervention for insistence on sameness

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

The VIPP-AUTI program, which involved five home visits, effectively reduced parental intrusiveness and increased parents' self-efficacy in raising children with Autism Spectrum Disorder, based on a study with 78 caregivers and their children aged 16-61 months.

At a 3-month follow-up, children whose parents participated in VIPP-AUTI showed improvements in joint attention skills, indicating that the intervention had a positive impact on certain aspects of child development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI): A randomized controlled trial. Poslawsky, IE., Naber, FB., Bakermans-Kranenburg, MJ., et al.[2022]

The pilot trial of the SPACE treatment for anxiety in autistic children showed high feasibility and acceptability, with 84.62% of eligible families participating and 68.18% completing the treatment.

After 13 weekly sessions, significant reductions in anxiety symptom severity and family accommodation were observed, with 86.66% of participants showing reliable improvement, which was maintained at a 2-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Trial of SPACE (Supportive Parenting for Anxious Childhood Emotions) in Autism. Rozenblat, S., Shimshoni, Y., Lebowitz, ER., et al.[2023]

The PEERS social skills intervention for adolescents with high-functioning autism significantly reduced family chaos compared to a waitlist control group, indicating a positive impact on family dynamics.

Parents participating in the PEERS program reported increased self-efficacy in their parenting, suggesting that the intervention not only benefits the child but also supports the parents' confidence and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent and family outcomes of PEERS: a social skills intervention for adolescents with autism spectrum disorder. Karst, JS., Van Hecke, AV., Carson, AM., et al.[2021]

Cognitive Behavioral Therapy (CBT) significantly reduced parent-reported autism symptoms in children with autism spectrum disorders and anxiety, with a strong effect size of 0.77 based on a pilot study of 19 children.

The benefits of CBT were not only evident immediately after treatment but were also maintained at a 3-month follow-up, suggesting lasting improvements in social communication and emotion regulation skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: effects of cognitive behavioral therapy on parent-reported autism symptoms in school-age children with high-functioning autism. Wood, JJ., Drahota, A., Sze, K., et al.[2021]

Parent-mediated interventions (PMIs) for children with autism spectrum disorders (ASDs) showed a small but clinically relevant improvement in parent-rated adaptive functioning, although the evidence is of low certainty based on a review of 30 randomized controlled trials involving 1,934 participants.

PMIs may help reduce disruptive behavior in children with ASD, with a moderate certainty of evidence indicating a significant effect, but no clear benefits were found for clinician-rated core symptoms or parental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Mediated Interventions for Children and Adolescents With Autism Spectrum Disorders: A Systematic Review and Meta-Analysis. Conrad, CE., Rimestad, ML., Rohde, JF., et al.[2021]

In a pilot trial of Parent-Child Interaction Therapy (PCIT) involving boys aged 5-12 with high functioning autism, the intervention led to significant reductions in parents' perceptions of their child's problem behaviors and atypicality, along with increased child adaptability.

The study highlighted the importance of shared positive affect between parents and children during therapy, as increased parent positive affect was linked to better perceptions of child improvement in behavior and functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of parent-child interaction therapy for families of children on the autism spectrum. Solomon, M., Ono, M., Timmer, S., et al.[2022]

In a study involving 57 children with autism spectrum disorder (ASD), parents who participated in cognitive behavior therapy showed significant improvements in their mental health, particularly in depression and emotion regulation, compared to those in a waitlist group.

The positive effects of the therapy extended beyond the children, benefiting all parents involved by enhancing their perceptions of their children and promoting mindful parenting, suggesting that parent involvement in therapy can lead to better outcomes for both parents and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Outcomes Following Participation in Cognitive Behavior Therapy for Children with Autism Spectrum Disorder. Maughan, AL., Weiss, JA.[2018]

A pilot study involving 21 parents of newly diagnosed children with Autism Spectrum Disorder (ASD) showed that a four-session positive parenting program led to significant reductions in maladaptive behaviors in children and improved family functioning.

The program was well-received, with 100% of parents reporting high satisfaction, suggesting that such interventions could be a feasible approach to support families in the early stages of an ASD diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot of a Brief Positive Parenting Program on Children Newly Diagnosed with Autism Spectrum Disorder. Zand, DH., Bultas, MW., McMillin, SE., et al.[2019]

Behavioral parent interventions have shown significant positive effects on reducing disruptive behavior in children with autism spectrum disorders, with a standardized mean difference of 0.67 based on data from nine randomized controlled trials.

These interventions also help reduce parent stress (standardized mean difference of 0.37), indicating benefits for both child behavior and parental well-being, although the impact on parenting efficacy remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysis. Tarver, J., Palmer, M., Webb, S., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37353645/

A Pilot Trial of SPACE (Supportive Parenting for Anxious ... This pilot trial examined the feasibility, acceptability, treatment-satisfaction, and preliminary efficacy of SPACE for anxiety in autism.

2. researchgate.net researchgate.net/publication/371808407_A_Pilot_Trial_of_SPACE_Supportive_Parenting_for_Anxious_Childhood_Emotions_in_Autism

A Pilot Trial of SPACE (Supportive Parenting for Anxious ... FA can be counterproductive as increased FA is associated with increased child OCD and anxiety symptom severity and impairment, poorer treatment ...

3. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.1001705/full

Comparison of the effectiveness of online supportive ... Our results demonstrated that FTTT significantly outperformed the SPACE program in reducing childhood anxiety problems and family accommodation levels.

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/21676968241252851

Preliminary Randomized Controlled Trial of the Supportive ... Our exploratory results indicate that SPACE-FTL reduces parental burden associated with caring for an adult child with FTL. Parents who support ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07219992

Parent-Based Treatment for Adolescent Anxiety This study aims to test the efficacy of a parent-only approach to treating anxiety disorders in adolescents: SPACE (Supportive Parenting for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6732048/

Parent-Based Treatment as Efficacious as Cognitive ... Supportive Parenting for Anxious Childhood Emotions (SPACE) is a parent-based treatment that reduces accommodation of childhood anxiety. This study compared ...

7. adaa.org adaa.org/learn-from-us/from-the-experts/blog-posts/consumer/lets-go-space

Let's Go To SPACE SPACE is all about empowering you, the parents, to be a rock-solid support system for your child dealing with anxiety.