Health TrialsbyHealthPanel

Improving Caregiver Engagement in Early Interventions

ConditionAutism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of California, Davis

About this trial

The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

currently providing early intervention services, including a caregiver-coaching component

having at least 1 child in the autism service classification on their caseload.

child is 12-60 months of age at the time of enrollment

child has a diagnosis or high likelihood of autism

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • FANS-EI

    Behavioral

    Social support related text messages delivered to supporters and caregivers; asynchronized educational materials for supporters.

  • Early Intervention

    Behavioral

    Treatment as usual provided by community-based autism early intervention agencies

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Treatment as usualActive comparator 1 intervention
Group B: FANS-EIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Parent Participatory Engagement Measure

The 5-item Parent Participatory Engagement Measure (PPEM) examines caregiver comfort with, engagement and participation in the intervention.

Time frame
Weekly for 6 months

Secondary outcomes

1

Caregiver Buy-In to EI

The extent to which caregivers value the changes called for by the EI, believe the EI is good for their child, and believe that the EI creates positive change in their child) on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree)

Time frame
baseline, 6 months
2

Parenting Sense of Competence Scale

A 17-item caregiver self-report questionnaire measures the degree to which caregivers feel competent and confident in parenting their children (i.e., efficacy) and their satisfaction with parenting. Items are rated on a 6-point Likert scale

Time frame
Baseline, 6 months
3

Social Support Index

A 17-item measure of caregiver-reported social support, rated on a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree).

Time frame
Baseline, 6 months
4

Acceptability of Intervention Measure

The 5-item Acceptability of Intervention Measure (AIM) will be used to measure acceptability of FANS-EI on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).

Time frame
6 months

Other outcomes

1

Coaching Practices Rating Scales

This measures practitioner use of coaching practices on a 5-point scale (1 = None of time to 5 = all of the time).

Time frame
Baseline, 2nd and 4th months, 6 months
2

Frequency of contact

Frequency of contact between the supporter and the caregiver

Time frame
Baseline, weekly until exit at 6 months
3

Vineland Adaptive Behavior Scales-3

This measures adaptive behaviors on a 3-point Likert scale (0 = never, 1 = sometimes, 2 = usually or often).

Time frame
Baseline, 6 months
4

MacArthur-Bates Communicative Development Inventory

MacArthur-Bates Communicative Development Inventory (CDI) assesses caregiver-reported communicative development in young children (8 - 37 months), including vocabulary, gesture, and emergence and expansion of grammatical features.

Time frame
Baseline, 6 months

Sponsors and contacts

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University of California, Davis

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: