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

Trial Summary

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 data supports the effectiveness of the treatment Supportive Parenting for Anxious Childhood Emotions (SPACE) for autism?

Research shows that SPACE, a parent-based treatment, significantly reduced anxiety symptoms and family accommodation in autistic children, with 86.66% of participants showing reliable improvement post-treatment, and these benefits were maintained at a 2-month follow-up. ^{1 2 3 4 5}

Is the Parent-Mediated Intervention for Autism safe for humans?

The Parent-Mediated Intervention, including SPACE, has been found to be feasible and acceptable with no reported adverse events in a pilot trial involving autistic children. Additionally, a systematic review found no significant adverse effects associated with parent-mediated interventions for autism spectrum disorders. ^{2 3 5 6 7}

How is the SPACE treatment for autism different from other treatments?

SPACE (Supportive Parenting for Anxious Childhood Emotions) is unique because it focuses on reducing family accommodation (changes parents make to ease their child's distress) to help manage anxiety in children with autism. Unlike traditional treatments like cognitive-behavioral therapy or medication, SPACE is a parent-based program that involves 13 weekly sessions and has shown to significantly reduce anxiety symptoms and improve family dynamics. ^{2 4 5 8 9}

What is the purpose of this trial?

This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.

Research Team

Jennifer Phillips, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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.

I have been diagnosed with ASD by a psychologist.

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

Exclusion Criteria

My child has significant hearing, language, or motor issues.

My anxiety or IS treatment has been stable for the last 2 months with no changes expected.

Caregivers who have participated in formal SPACE training

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

The effectiveness of parent-child interaction therapy for families of children on the autism spectrum. [2022]

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

Parent and family outcomes of PEERS: a social skills intervention for adolescents with autism spectrum disorder. [2021]

3. United States 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. [2021]

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

Parental Outcomes Following Participation in Cognitive Behavior Therapy for Children with Autism Spectrum Disorder. [2018]

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

A Pilot Trial of SPACE (Supportive Parenting for Anxious Childhood Emotions) in Autism. [2023]

6. England 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. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Parent-Mediated Interventions for Children and Adolescents With Autism Spectrum Disorders: A Systematic Review and Meta-Analysis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI): A randomized controlled trial. [2022]

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

A Pilot of a Brief Positive Parenting Program on Children Newly Diagnosed with Autism Spectrum Disorder. [2019]